glossary of terms applicable to the medical and … · abcess absorbable dusting ... a condition of...

Glossary of Terms Applicable to the Medical and Industrial Glove Industry

AAMI

Abcess

Absorbable Dusting Powder (ADP)

Absorbent

Accelerator

Acceptable Quality Level (AQL)

Acid Fast

Activated Cells

Characteristic of bacteria such as mycrobacteria, which involves resistance to decolorization by acids when stained by certain dyes.

A glove donning powder consisting of modified (cross-linked) cornstarch and less than 2% magnesium oxide as defined in the United States Pharmacopeia (USP). Phosphorous oxychloride or epichlorhydrin are utilized in the surface cross-linking. This process is performed to make the starch particle more resistant to breakdown during steam sterilization and when immersed in sweat from the hands. In fact, the USP requires that the powder must be capable of withstanding 20 minutes of boiling without disintegrating. Thus, the end product is not readily dissolved.

A destructive test methodology applied to a defined, partial quantity from the total manufactured products, of which an assessment of the entire production can be made.

Pull within the material (e.g. a sponge absorbs).

A chemical used as a catalyst to accelerate the cross-linking of liquid latex into a usable solid film. Primary accelerators used for making gloves are thiazoles (MBTs), thiurams, carbamates and thioureas (thiocarbamides, including dithiocarbamates). Accelerators are known to be contact sensitizers.

AAssociation for the Advancement of Medical Instrumentation. This organization is composed of a number of specialized task forces, with volunteer experts from government, industry and academia, that develop standards and guidelines as needed.

A cavity filled with pus (dead white blood cells and broken down tissues) and surrounded by inflamed tissue. Sterile abscesses are caused by a non-bacterial inflammatory response which may occur in acute or chronic inflammatory conditions.

Transformed cells that have achieved the capacity to exercise their full functional potential (e.g. activated macrophages, T-cells and mast cells). They activate, or turn on, when something in the environment triggers their need. For example: endotoxin, foreign bodies and inflammation activate macrophages; chemical contact sensitizers activate T-cells, etc.

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Acute

ADA

Adsorb

Aerobic

Aerosolization

Agar

Agriculture and Agri-Foods Canada

AHRMM

AIDS

Alkalinity

Allergen

Microorganisms that grow in the presence of oxygen.

Solid culture medium (an extract of sea weeds).

American Dental Association. The ADA is the professional association of dentists dedicated to serving both the public and the profession of dentistry. The ADA promotes the profession of dentistry by enhancing the integrity and ethics of the profession, strengthening the patient/dentist relationship and making membership a foundation of successful practice. The ADA fulfills its public and professional mission by providing services and through its initiatives in education, research, advocacy and the development of standards.

Association for Healthcare Resouce and Materials Management whose mission is to lead, educate and promote resource management supporting cost-effective, quality healthcare.

A substance, usually a protein, that is able to elicit an IgE antibody response and activate mast cells. Every allergen is a type of antigen but not every antigen is an allergen.

Free alkali content of latex (% of ammonia in the latex). Alkali have a pH of greater than 7.

Canadian requirements for the use of products (ie. Gloves) in the handling and preparation of food and agruculture.

To disperse as an aerosol. A suspension of fine solid or liquid in gas, such as air. A common factor in powdered latex gloves

Aquired Immune Deficiency Syndrome. Severe manifestation of infection with the human immunodeficiency virus (HIV). The Centers for Disease Control and Prevention lists numerous opportunistic infections and neoplasms which, in the presence of HIV infection, constitute an AlDS diagnosis. The increase in medical glove use over the past fifteen years can be attributed to HIV/AIDS proliferation.

Having a short and relatively severe course.

Adhere to the surface of a material (e.g. salt adsorbs to the surface of popcorn).

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Allergen Units (AU)

Allergic Contact Dermatitis

Allergy

Ambidextrous

Ammonia

Anaerobic

Anaphylactic Shock

Anaphylaxis

Anatomical

Microorganisms that grow in complete or nearly complete absence of oxygen.

Used in ELISA inhibition testing for allergenic proteins. Given as AU/ml (Allergen Units per mililiter). Gives total number of allergenic proteins found in sample. <100-500 AU/ml is low, 500-1000 AU/ml is moderate and >1000 is high. For Sempermed gloves, this testing is conducted by the Mayo Clinic.

An allergic rash (Type IV) with physiological memory to the chemical sensitizer which caused it (meaning it will cause it again with subsequent exposure).

Effective for either left or right hand use.

Specific to prescribed body parts of an organism (ie. right and left hand); not ambidextrous.

A Preservative and stabilizer used in latex concentrate.

Ana-phy-lac-tic shock: an often severe and sometimes fatal systemic reaction in a susceptible individual upon exposure to a specific antigen after previous sensitization. Characterized by respiratory symptoms, fainting, itching and urticaria.

Ana-phy-lax-is: hypersensitivity resulting from sensitization following prior contact with the causative agent. An immediate systemic allergic reaction to a foreign protein or other substance. The reaction results from the release of histamine and other substances when allergen combines with IgE antibodies on mast cell surfaces. There are receptor sites for histamine on the surface of blood vessels. When triggered, the vessels dilate, letting fluid (not red blood cells) leak out into the surrounding area. This can be local, as seen in the raised surface of a hive, or it may the systemic. If the release of fluids from the circulatory system is systemic, the lost volume results in hypotension (drop in blood pressure). The heart increases its speed to compensate (tachycardia). If sufficiently severe, it can lead to anaphylactic shock and, rarely death.

The immunologic state induced in a susceptible individual by an allergen characterized by a marked change in the subject’s reactivity. Both Type I and Type IV hypersensitivities are allergies (e.g. Type I = latex protein allergy, hay fever, penicillin allergy; Type IV = chemical accelerators, nickel, poison oak).

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Angioedema

ANSI

Antibody

Antibodies

Antibiotic

Antigen

Antigenic Chemicals

Antimicrobial

Antioxidant

AORN

Substance produced by microorganisms which inhibits or kills another microorganism.

Association of Operating Room Nurses. AORN represents more than 43,000 registered nurses who facilitate the management, teaching, and practice of perioperative nursing, or who are enrolled in nursing education or engaged in perioperative research. It's mission is to promote quality patient care by providing its members with education, standards, services, and representation.

A substance added to latex and synthetic gloves to prevent or delay deterioration of the glove by the oxygen in air.

A protein or carbohydrate substance capable of eliciting an immune (antibody or cellular) response; a molecule that causes the creation of and subsequently combines with the antibody or antigen-specific receptor on a T-cell. Both thiuram (Type IV contact sensitizer) and natural rubber latex proteins (Type I allergen) are antigens.

Chemical contact sensitizers that can elevate the level of sensitization for patient and healthcare provider, potentially resulting in allergic contact dermatitis (Type IV, delayed type hypersensitivity) externally or granulomas internally.

Diffuse swelling. In Type I reactions, swelling of the lips and periorbital (around the eyes) often occurs.

American National Standards Institute. ANSI endorses standards and guidelines for the U.S. but does not actively create them.

Any of a large number of proteins of high molecular weight that are produced normally by specialized B cells after stimulation by an antigen and act specifically against the antigen in an immune response.

A substance formed in the body that reacts specifically with a protein or allergen which causes Type I hypersensitivity (IgE) or resistance to infection (IgA, IgD, IgE, IgG, IgM). The Ig stands for immunoglobulin and the A, D, E, G, and M are the categories of antibodies, each serving a slightly different function.

Capable of destroying or inhibiting the growth of microorganisms

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APIC

Apnea

AQL

ASQC

Asthma

ASTM

ASTM Standards

ASTM D412

ASTM D3577

ASTM D3578

ASTM D5151

ASTM D5250

ASTM D5712

ASTM D6124

ASTM D6319

Asymptomatic

Association for Professionals in Infection Control and Epidemiology. APIC is a multi-disciplinary, voluntary, international organization. APIC promotes wellness and prevents illness and infection world-wide by advancing health care epidemiology through education, collaboration, research, practice, and credentialing.

Standard Specification for Nitrile Examination Gloves for Medical Application

Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and its Products Using the Modified Lowry Method

A condition of the lungs in which there is widespread narrowing of the airways. Most cases represent a chronic form of allergy due to IgE antibodies. Irritant asthma is activated by irritants such as a chemicals or particles.

Standard Test Methods for Rubber Properties in Tension

Standard Test Method for Detection of Holes in Medical Gloves

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

See Acceptable Quality Level

American Society for Quality Control

Transient cessation of breathing

American Society of Testing and Materials. The ASTM issues testing standards and specifications. The FDA utilizes many of the standards developed by ASTM to establish medical device requirements.

Without symptoms. An asymptomatic individual does not display reactions.

American Society for Testing and Materials. Describe certain requirements and testing methods for gloves used in conducting medical examinations, diagnostic and therapeutic procedures. They also cover gloves used for handling contaminated material.

Standard Specification for Rubber Examination Gloves

Standard Specification for Rubber Surgical Gloves

Standard Test Method for Residual Powder on Medical Gloves

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ATCC

Atopic

Atopy

American Type Culture Collection, vast collection of bacteria including many different types and strains.

A person with a hereditary tendency to develop IgE-mediated hypersensitivity, usually having multiple allergies to substances such as ragweed, cat dander, dust mites, pollens and foods.

A hereditary tendency to develop IgE-mediated states of hypersensitivity, such as hay fever.

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Bacteria

Barrier Protection

Basophil

Bead Faults

Beaded Cuff

Bioburden

Bio-Compatibility

Bisque

Blood-borne Pathogens

B Lymphocyte (B-cell)

Break-through Time

Infectious organisms in the blood, of which the predominent medical interest is their contamination of gloves, etc., all of which health workers are exposed to. Differentiated from organisms present in the blood as a result of natural infectious process.

A glove finish characterized by a less glossy surface and decreased slickness.

To protect oneself from elements and blood borne pathegens.

A blood granulocyte with large stores of anaphylactic mediators and receptors for IgE. They may be thought of as mast cells in the blood. See Mast cells.

Open spots, tears etc. that cause bad cuffing.

Microscopic organisms that have the potential to grow into harmful colonies, or penetrate examination gloves through defects, punctures or tears. Bacterium (singular). The smallest organisms that contain all the mechanism required for growth and replication.

Rolled or "beaded" open end of a glove. Beading increases component strength, and effectively adds protection against fluid drip.

Time elapsed between initial chemical contact and detection of the chemical inside the glove.

A test to determine the bacteria present on any given product. The total number of viable bacteria and fungi on a packaged item prior to irradiation.

Responsible for the production of immunoglobulins (antibodies) of all types: IgA, IgD, IgE, IgG, IgM. As the B-cell is activated or transformed and begins production of antibodies, it becomes known as a plasma cell.

A test to determine whether a product causes irritation, sensitization to a group of subjects, human or animal.

B

bacteria

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Calcium Carbonate

Caution Statement

CDC

CE

CE Category I-III

Center for Disease Control in Georgia, investigates outbreaks of disease, causes of diseases and potential cures.

I: Lightweight protective gloves for which the user can assess their effectiveness in terms of slight risks. Marking of glove packaging with the CE symbol. II: Protective gloves against intermediate risks, which have been tested in accordance with standard EN 388 (Protection Against Mechanical Risks), EN 374-2 (Protection Against Micro-Organic Risks), and EN 374-3 (Protection Against Chemical Risks) and for which the user will be able to judge the immediate effect. Marking of glove packaging with the CE symbol. III. Protective gloves against complex and irreversible risks which will only offer time-limited protection and where the user will not be able to recognize the immediate effect. The gloves have been tested as in Category II, in addition the production or products undergo checks at regular intervals by a notified body (according to Directive). Marking of glove packaging with the CE symbol and with the identification of the notified body.

FDA requirement for NRL glove products which states that "This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."

A mold-release agent often used to facilitate the release of latex gloves from their porcelain molds (formers). Calcium carbonate is a non water-soluble crystal. It occurs in nature as oyster shells, chalk and limestone. The chlorination process utilized to produce powder-free gloves removes the calcium carbonate.

Continuing Education. Programs designed to provide required contact hours to registered nurses who desire to remain licensed in their given state. Also see CEU.

C

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CE Mark

Centrifugation

CEU

CGMP

Checking

Chemical Residuals

Chemical Resistance

Chemical Resistant Gloves Construction and composition of materials provide resistance to a wide range of chemicals.

"CE" marking on product packaging. Indicates conformity to the legal requirements of the European Union Directives for safety and health. Many of the EU (EU) Directives require manufacturers to be ISO 9000 certified in order to legitimately apply the CE marking to their product. Although the “CE” abbreviation is thought to refer to ‘Conformité Européenne,’ or the Latin or French translation of European Community, it actually does not refer to any particular phrase or title.

Current Good Manufacturing Practices, guidelines proposed by FDA to assure quality in production of biomedical products.

Chemical compounds are used during the manufacturing of gloves, which may remain in varying amounts. Water leaching helps reduce these residuals.

The process of rotating latex, which separates the compound, concentrates the rubber content up to about 60%, and also reduces the protein content. Double centrifuging can reduce protein content even further

Gloves may undergo 100% testing by air inflation. In addition, some gloves will be removed and tested by the water method (which is a more sensitive test) for pinholes as part of the routine quality assurance process. Other tests will also be performed, such as tensile strength tests. See Quality Assurance.

The ability of a product to maintain its integrety when exposed to chemicals.

Continuing Education Units. Units are awarded to registered nurses based on the number of contact hours of continuing education obtained. For example, 10 contact hours can equal one CEU. States require a specified number of CEUs to retain licensure

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Chemotherapy (Chemotherapeutic)

Chlorines

Chlorination

Chloroprene

Circumscribed

Class I Medical Device

Class II Medical Device

2-Chloro-1,3-Butadiene. A colorless liquid organic compound used in the synthesis of neoprene and certain other rubbers. The structure of the chloroprene molecule is very similar to that of isoprene; the molecule contains two double bonds and is readily polymerized.

Instead of powdering, some manufacturers dip gloves into a chlorinated solution (for example, sodium hypochlorite acidified with hydrochloric acid). This process reacts with the natural rubber latex to reduce tackiness, eliminating the need for additional dusting powder. Also, extra washing performed during chlorination provides an added benefit by greatly reducing the level of soluble latex proteins. It also affects some mechanical and physical glove characteristics (e.g. softness and color).

A device for which the controls authorized by or under sections of the Federal Food, Drug and Cosmetic Act are sufficient to provide reasonable assurance of the safety and effectiveness of the device.

A device that cannot be classified as a Class I device because the sections of the Federal Food, Drug and Cosmetic Act by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device and for which there is sufficient information to establish special controls to provide such assurance, including the dissemination of guidelines.

Within a well-defined area or in one with definite boundaries or limits. A hive has a circumscribed region of swelling.

See Chlorination. Corrosive compounds that can burn skin and eyes, as well as discolor fabrics and vinyl. They are inactivated by protein based materials and are not registered by the EPA. Common brands include Clorox.

The treatment, mostly of cancer, using a series of cytotoxic drugs that attack cancerous cells. This treatment commonly has adverse side effects that may include the temporary loss of the body's natural immunity to infections, loss of hair, digestive upset, and a general feeling of illness. Although unpleasant, the adverse effects of treatment are tolerated considering the life-threatening nature of the cancers. Gloves can be tested for use with chemotherapeutic drugs. The FDA currently requires testing to publish the claim that any glove is appropriate for use with chemotherapy drugs. Appropriate products include thicker (greater than 0.10 mm) latex and nitrile examination gloves.

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Class III Medical Device

Clean-room

Coagulant

Coccus

Coliform

Colony

Color

Compounding

Bacteria that appear spherical (plural-cocci).

Common name for bacteria such as Escherchia coli , a common animal gut organism. A subset of the Enterobacteriacea.

A device that cannot be classified as a Class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the special controls would provide reasonable assurance of its safety and effectiveness. They are purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury.

A room in which contaminants such as dust are reduced to a very low level by special procedures so that operations such as the manufacture and assembly of delicate equipment or the manipulation of biological materials can be performed effectively. Clean-room gloves are widely found in the electronic and pharmaceutical (Lab) industries. There are several clean-room class types, the lower the class number the cleaner the environment/less particulate allowed: Class 1 (M1.5), Class 10 (M2.5), Class 100 (M3.5), Class 1000 (M4,5), and Class 10000 (M5.5).

A group of individuals or things with common characteristics or interests situated in close association. Visible growth of a microorganism on solid culture medium.

Something that produces coagulation, the thickening of, or gathering together of a substance into a mass or group.

During the glove manufacturing process, chemicals are added, including accelerators (which help control the later vulcanisation process) and antioxidants (which prevent deterioration of the rubber molecules in the final product by heat, moisture and ozone).

Glove color is often asthetic and preferential, but can be used to designate use, type, or composition. It can also designate contaminated areas or differentiate among work areas.

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Contact Plate

Contact Sensitizer

Contact Urticaria

Controlled Environment Gloves

Copolymer

Cornstarch

Corrective/Assurance Action

CR

Controlled environment glove materials must provide protection against particulate contamination. They are widely used in electronics and pharmaceutical industries. Critical environment gloves are typically Class M 3.5 (Class 100) and cleaner. Less sensitive environments include M 4.5 (Class 1,000) and M 5.5 (Class 10,000) and higher. Controlled environment gloves are made from polyester, nitrile and nitrile/rubber combinations, natural rubber latex, polyvinyl chloride (PVC) and polyurethane.

Clean Room, an environment void of dust, static and other foreign matter. Also technical abreviation of Chloroprene (see above).

Contact urticaria or hives may appear within minutes to an hour after a sensitized individual comes in contact with allergens to which he/she is allergic. It is a Type I hypersensitivity reaction.

A modified solid medium used to determine extent of contamination or environmental surface.

A medical grade donning agent made from corn, under USP requirements for use as a donning agent on medical grade gloves.

A compound made by polymerizing two or more dissimilar monomers

A chemical agent used in the manufacturing process of latex rubber that may elicit a delayed type allergic reaction (Type IV) after repeated contact with the epidermis of a susceptible individual. The Type IV reaction is usually triggered when the contact sensitizer dissolves in perspiration and is absorbed through the epidermis. Symptoms are usually mitigated with time after removal of the offending substance from skin contact. The most common latex-related contact sensitizers are accelerators such as thiurams, mercaptobenzothiazole and carbamates. Other chemical additives (antioxidants, preservatives, etc.) have been reported as possible contact sensitizers, for example Butylhydroxyanisol (BHA) and 3,5-di-tertiary butyl 4-hydroxytoluene (BHT) 4,4-thiobis (6-tertiary butyl) meta cresol (Lowinox 445S6) and amine derivatives IPPD, CPPD, DPPD.

The act of altering a process variable in order to change an operating condition in a system to correct a fault in the process and/or improve quality.

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CR.. 10,100,1000

Cross-Linking

Cross-Reactive Proteins

kiwi potatomango ragweedmelon ryemugwort timothy grassnectarine tomato papaya wheatpassion fruitpeach pear

Cuff

Cut-Resistant Gloves

Cytokines

Cytotoxic

Cytotropic

figs

Antigens which differ from one another but are similar enough that they can react with antibodies raised against either one of them. Cross-reactive proteins that may combine with latex IgE antibodies include:

A level of Environmental Cleanliness and product cleanliness. The lower the number, the more sensative the controlled environment. All controlled environment glove materials must provide protection against particulate contamination. A prescibed washing and cleaning process removes particulate matter from gloves.

Having an affinity for cells. IgE antibodies are cytotropic for mast cells.

Cytokines are chemicals, released from cells, that signal other cells to the area, activate specific cell types, "turn off" cells and regulate other activities as needed.

grape hazelnut

pineapple plum

Upper portion of glove encircling the wrist. Designs range from straight, pinked, rolled (beaded), or fluted. Gauntlet cuffs offer the benefits of a safety cuff, plus a flared design that fits over the sleeve.

No material is completely puncture or cut resistant, but certain materials offer superior protection against abrasion and laceration from knives, instruments, or sharp edges.

appleapricotavocadobananabuckwheatcarrot

Cross-wise connecting part that connects parallel chains in a complex chemical molecule (as a polymer).

celerycherrychestnut

Injures cells. Demonstrated using tests such as hemolysis, medium eluate method (MEM), agar overlay and embryo toxicity.

cuff

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Decontamination

Degradation

Degranulation

Delamination

Delayed Hypersensitivity (Type IV or Chemical Allergy)

Denature

Dermal

Dermatitis

Of, or relating to the skin (Epidermal).

The expulsion of granules from a sensitized mast cell when triggered by an allergen (Type I reaction). Granules include stored mediators such as histamine. The cells then resynthesize new stores of mediators and continue their patrol.

D

Separation into constituent layers, such as that of a bonded layer from natural rubber latex.

The use of physical or chemical means to remove, inactivate or destroy bloodborne pathogens to the point where they are no longer capable of transmitting infectious particles.

Deleterious effects that liquid chemicals, extreme heat, ozone, fatigue, oil or other substances have on the physical properties of gloves. Tell-tale signs of degradation may include softening and tackiness, brittleness, loss of elasticity, growth or creep at the fingertips.

To change irreversibly the structure or conformation, and thus the solubility and other properties, of a protein by heating, shaking, or treating with acid, alkali, or other species.

Initiated by antigenic chemicals (chemical contact sensitizers) on the skin, this delayed hypersensitivity causes the symptoms of allergic contact dermatitis such as itching, red appearance; small blisters; dry, thickened skin; crusting; scabbing sores; papules; peeling and vesicles. In the wound, symptoms include granulomas and adhesions as well as tissue, skin graft, implant and transplant rejections.

A general term referring to any inflammation of the skin; may be caused by irritation or Type IV (delayed type hypersensitivity). Characterized by erythema (redness), pain, pruritus (itching), vesicles (tiny blisters) and papules (hard bumps). If the dermatitis continues to occur for a long period of time (becomes chronic), symptoms may expand to include drying, scaling, peeling and keratosis (thickening and hardening of the skin).

dermatitis on forearm

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Dermatitis , Non-Allergenic

Dermatitis Type I

Dermatitis Type IV

Detention

Device Labeling

Dipping

Disease

Disinfectants

Disposable

D-Max

The process of submerging glove formers (molds) into tanks containing a compound or solution. The hand-shaped formers are coated with coagulant (e.g., calcium nitrate) and dipped into the latex to coat them with a thin film of latex. The coagulant converts the liquid latex film into a wet-gel on the former. Subsequent passage through a warm oven completes the coagulation process.

The maximum radiation dose that can be delivered to a product before unacceptable damage occurs.

Contact dermatitis usually occurs one to two days after contact with the offending product. This delayed-type is hypersensitive reaction is typically due to excess residual chemicals utilized as accelerators and antioxidants in the manufacturing process.

Products or a company placed on different levels of "hold" or denial from entering the United States until approved through the FDA.

Labeling requirements for medical devices have been established in the Food, Drug, and Cosmetic Act, 21 U.S.C. Title 21 and in the regulations promulgated under the act in the Code of Federal Regulations. General labeling requirements can be found in Part 801.

Three levels are recognized: High Level Disinfectants are chemical germicides that are registered as "sterilants" with the U.S. EPA and may be used for either sterilization or high level disinfectants of medical devices. Intermediate Level Disinfectants are chemical germicides that are EPA registered to inactivate M Tuberculossis var. bovis. Low Level Disinfectants are chemical germicides that are EPA registered as a hospital disinfectant but not a sterilant or tuberculocidal product. Delivery methods include aerosols, spray pumps, concentrates and foam.

Intended and designed for single-use only.

The most common form of perceived allergy; but, in fact, it is not an allergy. Cause: Frequent hand washing, strong surgical scrubbing, soaps, detergents, glove powder, and occlusion caused by gloves.

Hypersensitive Protein contact dermatitis is caused by special human antibodies. Instant allergies are presented usually within 30 minutes after allergen contact. Cause for type I allergies are the proteins contained in latex.

A departure from health or normal function (e.g. a broken bone, chicken pox, a sprained ankle, an allergy).

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D-Min

DNAse

Doffing

Donning

Donning Powder Caution Statement

Dose Audit

Dose Mapping

Dose Setting

Dosimeter A device that measures the amount of radiation which reaches the position where the dosimeter is placed.

A study performed to determine where maximum and minimum radiation hits products when sterilized. Dose mapping must be repeated whenever the glove, packaging box density, loading configuration or the sterilizing energy source changes so that the radiation penetration profile may be altered.

To remove; to dress out

A set of procedures performed to make sure the dose is still correct. The population and sterilization resistance of microorganisms vary with environmental conditions such as temperature and moisture. Thus, verification of the appropriateness of the sterilizing dose is performed quarterly as a dose audit.

The minimal radiation dose required to sterilize the product to the desired sterilization assurance level (SAL).

To put on; to dress in.

An enzyme that breaks down DNA. If it is present on standard gloves, additional processing is required for its removal. DNAse should be considered when running laboratory DNA isolation, purification and characterization studies.

Method 1, "Dose Setting using Bioburden Information." Determine the number of organisms on the packaged, pre-sterilized gloves. This is followed by irradiation with a dose taken from a table in the AAMI manual calculated to kill 90% of that number of microorganisms. If this sub-lethal dose actually kills at least 90% of the micro-organisms, the standard radiation dose is verified as adequate.

Because glove powder represents a potential hazard to the user and patient (particularly in association with natural rubber latex proteins) the FDA recommends the following statement appear on glove packaging: "Caution: Users should consider the circumstances of use in deciding whether to remove residual powder on glove after donning. Powder can be removed by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective methods."

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Double Glove

Double Wall

Draize Test (200 Person Modified Draize Test)

Dry Gel Leaching

Dyshidrosis

Dysfunction

Dyspnea

A condition of dermal breakdown (irritation) aggravated by constant, long-term contact with sweat in an occlusive environment, as under a glove without frequent changing. Vesicles, or tiny blisters, which are very painful often appear. This is most frequently seen in factory, cleanroom (e.g. semiconductor) and custodial employees.

Difficulty breathing; shortness of breath.

Placing one glove on your hand and then another over the first.

Measurement criteria whereby calipers are placed on both outer surfaces (eg. Finger, palm, or cuff) and double thickness results are reported

Occurs after gloves pass through ovens, transforming them from a gel into a basic solid form. When gloves are dry gel leached before the application of powder, their proteins may be reduced by 80-90%.

200-person challenge test utilized to determine irritant or dermal reactions caused by chemicals of a given product. Samples of the test glove are patch tested repeatedly on each of the individuals over a 6-week period.

Impaired or abnormal functioning.

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Eczema

Edema

ELISA Test

Elongation

EN

EN 46001

Endotoxic Shock

Endotoxin

Enterobacteriaceae The family of the most commonly encountered gram-negative rods found in clinical specimens.

Swelling. An accumulation of an excessive amount of watery fluid in cells, tissues or serous cavities.

The process of increasing length or lengthened through stretching. The amount a substance (rubber film) will increase in length before breaking at certain percentage intervals. A measurement in percent of the length a glove material can be stretched before it breaks.

EDermatitis of the skin, often of unknown origin, marked early by redness, itching, minute papules and vesicles, weeping, oozing and crusting; and later by scaling, thickening and hardening of the skin. Causes may be allergic or non-allergic. Atopic individuals often have had periods in their life when they had breakouts of eczema on the hands, legs, inside of the elbows or behind their knees.

See Enzyme Linked Immunosorbent Assay

Pyrogenic lipopolysaccharides from the cell wall of dead gram negative bacteria, capable of causing multiple local and systemic pathological sequela, including fever, complement activation, cell lysis, tissue inflammation, diarrhea, microthrombi formation, disseminated intravascular coagulation (DIC) and endotoxic shock.

Compliance with the European Quality System Regulation (QSR) specifically governing medical devices. In conjuction with ISO 9001, this European standard defines the requirements for quality systems of medical devices and embraces the principles of good manufacturing practice (GMP) widely used in the manufacture of such devices.

European Norm (EN) certification indicates compliance with the European Quality System Regulation (QSR).

Physiologic response resulting from a high dose of endotoxins into the blood stream. There is a sudden outflow of fluid from the blood vessels resulting in blood pressure drop (hypotension) which can cause the body to go into shock due to lack of sufficient oxygen supply to the tissues.

eczema on arms

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Enzyme Linked Immunosorbent Assay (ELISA)

Epidermis

Erythema

ESD (Electrostatically Dissipative)

European Union

Expiration Date

The outer or external layer of the animal body (skin) or a thin surface layer of tissue in higher plant forms.

Inflammatory redness of the skin.

Organization of eleven European countries; Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Finland, France, Luxemburg, Netherlands, Portugal, Spain, Sweden, and the United Kingdom. The mission of the EU is to organize relations between member states.

Specially treated and processed gloves designed to dissipate electrostatic charges. They are particularly suited to cleanroom applications involving sensitive electronic components.

The date after which a material should not be sold or used, often stamped on commercial products.

A highly sensitive immunoassay for specific antibodies or antigens (including allergens) depending on how the test is set up. Results expressed as microgram per gram or milliliter (_g/g or mL); parts per million (ppm); allergen units per gram or milliliter (Au/g or mL).

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Facultative

Fastidious

FDA

FDA 21 CFR

FDA 501(k) Number

FDA Import Alert 80-04

FDA,ODE

FDA,OC

Microorganisms that can grow either aerobically or anaerobically.

Organisms requiring complex nutritional and/or environmental living conditions.

Surveillance and detention without physical examination of surgeon's and/or patient examination gloves. Automatic detention program developed by the FDA to monitor and control glove products manufacturerd by firms who repeatedly import non-compliant products. There are three levels of alert status which may result in the detention of product without physical examination by the FDA. Approved testing be an indepentdent lab may also be required to release the product for use. Search current manufacturers on Import Alert: http://www.fda.gov/ora/fiars/ora_import_ia8004.html. Search current product on detention: http://www.fda.gov/ora/oasis/1/ora_oasis_i_79.html

O ffice of D evice E valuation

Food and Drug Administration, a government agency that monitors medical device product quality. Home page: http://www.fda.gov/

F

Section 510(k) of the Food, Drug and Cosmetic Act requires that device manufacturers must register to notify the FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification, which allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories (Class I, II, III). Devices are awarded specific numbers for each product. Profound product modifications may require a new 510(k) number. Search FDA Releasable 510(k) database: http://www.fda.gov/cdrh/510khome.html

Code of Federal Regulations, published in the Federal Register. Guidelines and test methods for assuring acceptable quality levels of food, drug, and medical products. Part 800 details patient examination and surgeon's gloves.

O ffice of C ompliance

Sample:K970794

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FDA,ORA

Film

Finish

Fissure

Flare

Fomite

Former, hand

Fungus/Fungi

Fusion Bonding The act of fusing; the state of being fused; a melting by heat; the uniting of various elements into a whole as if by melting together.

An inanimate object that serves to transmit an infectious agent from one person to another.

The finish can provide better grip in wet or dry applications. Patterns are put directly onto the glove form as it is cast for embossed, sandblast or recessed diamond finish. For bisque finish, the glove form is cast and then slightly roughened. For extra gripping power, some supported gloves receive a textured wrinkle, applied rough particle, or embossed self-flushing (tire or tractor-tread) finish. Gloves with a smooth finish rely on the gripping qualities of the material itself.

Horizontal cracks in the skin most notable in irritation reactions.

O ffice of R egulatory A ffairs

The finished, cured or semi-cured film made from suspended latex compound.

A diffuse area of redness on the skin due to increase dilation of the local blood vessels. Flares are usually present surrounding the wheals of a hive, projecting outward like rays.

A device manufactured in the shape of a hand used to dip into latex material to manufacture gloves.

Spore-producing organisms usually classified as plants lacking chlorophyll and include molds, rusts, mildews, smuts, mushrooms, and yeasts.

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Gamma Irradiation/Sterilization

Gauge (Thickness)

Genetically Predisposed

Glutaraldehyde

GMP

Gram Negative

Gram Positive

Granulocyte

Granuloma

Stains blue/purple as a result of the Gram Stain procedure.

Stains pink/red as a result of the Gram Stain procedure.

A subgroup of leukocytes (white blood cells), filled with granules of toxic chemicals that enable them to digest micro-organisms by phagocytosis.

Calcified nodules formed by the body as a protective, walling-off of foreign bodies or chronic inflammatory conditions caused by long-term irritants, infections or the presence of particles triggering a Type IV response. Those resulting from powder contamination are characterized microscopically by a Maltese cross design under polarized light. Granuloma nodules may remain long after the starch particles at their centers dissolve.

Good Manufacturing Practices

Glove thickness is measured in gauge, mil or millimeter. Low gauge (thin) gloves provide more flexibility and sensitive touch, while higher gauge (thicker) gloves offer more protection.

This describes an individual with the DNA capability to physiologically act in a particular way. In the case of Type IV (delayed type hypersensitivity) to specific chemicals in a glove, a genetically predisposed individual is capable of forming receptor sites to that chemical on their T-cells. In the case of immediate or Type I hypersensitivity, a genetically predisposed individual is capable of producing IgE antibodies to latex (or cross-reactive) proteins.

A popular method of sterilization in the healthcare industry using electromagnetic radiation (bombardment of high energy photons=gamma rays), rather than chemicals such as Ethylene Oxide.

A nonflammable liquid, C5H8O2, soluble in water and alcohol, toxic and an irritant, used for tanning leather and as a fixative for samples to be examined under the electron microscope. It is harmful to the eyes, can burn and discolor skin, and cause severe contact dermatitis. Brands include Cidex, Procide, Omnicide and Waveside. Gloves are required to handle this chemical.

G

granuloma

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Guthrie Donald Guthrie Foundation for Education Research. The Institute was founded in 1976 to advance knowledge of biology and disease through basic biomedical research. The Latex ELISA for Antigenic Protein (LEAP) Testing Service is an independent testing laboratory at the Guthrie Research Institute in Sayre, Pa. Directed by Donald Beezhold, Ph.D., the testing service specializes in testing natural rubber latex products, such as gloves, for the assessment of latex protein levels.

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Halogenation

Hapten

Harvesting

Hat Yai

Hemolysis

Hevea brasiliensis

HIBC

Lysing of Red Blood Cells.

To treat or cause to combine with a halogen. Halogens consist of any of the five elements of flourine, chlorine bromine, iodine and astatine.

A small biochemical group that initially by itself cannot elicit an allergic response. It must conjugate (join) to a carrier (usually protein) to elicit an antibody response. Once it is recognized with a carrier, the body may recognize the hapten without the carrier.

Health Industry Bar Code. Similar to UPC (Universal Product Code), but specifically designed for the healthcare industry. Uses bar code technology for automated product identification. Commonly employed encoding are Code 128 and Code 39 symbology. Code 39 (Also Called Code 3 of 9) is suitable for encoding general purpose alphanumeric data. The Code 39 system is a self-checking, alpha-numeric bar code, which encodes 43 characters; zero through nine, capital "A" through capital "Z", minus symbol, plus symbol, forward slash, space, decimal point, dollar sign and percent symbol. Each character is encoded by 9 bars, 3 of which are always wide. More condensed than Code 39, Code 128 is suitable for encoding general purpose alphanumeric data and provides high information density encodation of numeric data strings.

Pronounced HiJi , The Thai city of Hatyai (Hat Yai) is located approximately 15 miles north of the Malaysian border in the southern province of Songkhla (pronounced Sung-glue-ha ). The city where Sempermed product is manufactured.

Pronounced Hav-e-ya braz-il-i-en-sis , Originating in brazil, the Hevea tree is now commercially cultivated in many tropical countries for the milky viscous sap called latex.

H

The process of tapping a rubber tree for the milk-like latex.

Code 39

Code 128

leaf

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HIDA

Histamine

HIV

Hydration

Hyper

Hypersensitivity

Hypo

Soluble materials in latex, such as manufacturing chemicals, are dissolved by perspiration, blood, or body fluids. As the hydration process continues, the strength of the latex barrier deteriorates, increasing the risk of glove failure.

A highly vasoactive (acts on the blood vessels) substance liberated in large amounts from basophils and mast cells during allergic (immediate type hypersensitivity - Type I) reactions. The release is triggered when the allergen attaches to the IgE antibodies on the surface of the cells. Histamine causes dilation of capillaries, a decrease in blood pressure, increased secretion of gastric juice and constriction of the small tubes (bronchii) in the lungs.

The probable cause of AIDS. A human retrovirus of the lentivirus family, notable for long duration of asymptomatic infection, often followed by progressive deterioration of cell mediated immune function, and eventual opportunistic infection and neoplasm. The median time for an HIV infected individual to develop full clinical AIDS is probably over ten years (formerly called HTLV III or LAV). The increase in medical glove use over the past fifteen years can be attributed to HIV/AIDS proliferation.

Above, higher than normal, as in hyperactive, hypertension (high blood pressure) or hypersensitivity.

Health Industry Distributors Association. Trade association representing medical and healthcare products distributors. Since 1902, HIDA has provided leadership in the medical distribution marketplace through special programs, benchmarking surveys and new product development.

Term used to describe an exaggerated response to a substance (i.e. an antigen), developed after repeated exposure, causing a genetically predisposed (atopic) individual to become sensitized or allergic (Type I or Type IV).

Below, under, deficient, containing less than usual such as in hypodermic (under the skin), hypotension (low blood pressure).

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Hypoallergenic As a term for gloves, the claim hypoallergenic was developed to describe a reduced potential for developing a dermatological response to chemicals utilized in production of a given product. The 200-person Modified Draize test is used to determine potential irritancy or allergic contact dermatitis (Type IV) to the product. After producing product to meet these requirements, manufacturers were allowed to utilize the term hypoallergenic as an identifier for the product (a claim). However, in recent years individuals have also developed Type I allergic reactions in association with the proteins in gloves. Because the label claim of hypoallergenic was being interpreted to refer to both Type IV (chemicals) and Type I (protein) allergies, rather than just Type IV, this claim was removed from all gloves September 30, 1998.

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Iatrogenic

Ig

IgE

IgG

Immunoglobulins

Induration

Industrial Gloves

Infection

Attaches to foreign bodies as well as bacteria to incapacitate and assist in their destruction. These are the antibodies created by the body when individuals are inoculated with vaccines.

Invasion and multiplication of microorganisms in body tissue resulting in disease.

Hardness, caused by inflammatory swelling with excessive influx of white blood cells.

Any non-medical, general purpose glove meeting specific environmental and use requirements as prescribed by ISO, ASTM, CE, EN, FDA, or other standards or regulating bodies. Industrial gloves are ranked by use (general purpose, cleanroom, food, etc.) and/or risk (minor, intermediate, or complex).

Immunoglobulin E (IgE Antibodies). A class of immunoglobulins that function in allergeic reactions. IgE antibodies are the hallmark of a Type I allergy (e.g. penicillin, peanut, latex protein). Antibody that is made after contact with an allergen in genetically capable individuals. Once made, IgE antibodies attach to mast cells (in tissues) and basophil cells (in blood) and mediate immediate type hypersensitivity reactions (Type I).

An adverse patient condition caused by the treatment or diagnostic procedures. An iatrogenic disorder is a condition caused by medical personnel or procedures or through exposure to the environment of a health-care facility.

I

See Antibody

Antibodies (immunoglobulin) of any of the five classes: IgA, IgD, IgE, IgG and IgM.

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Inflammation

Integrated Manufacturing

In Vitro

In Vivo

Irritant Contact Dermatitis

Irritation

ISO

Within the human or animal body

"Within glass", under test conditions-e.g. in test tubes or on Petri dishes.

Dermatitis develops when a substance repeatedly chemically injures, physically abrades or otherwise damages the skin.

Cellular or systemic response to physiological, chemical or biologic injury. Inflammation occurs as a part of irritation, Type I and Type IV reactions. An extremely dynamic pathological process in which the blood vessels dilate, releasing fluids to the local area. Leukocytes, or white blood cells (WBC) enter, releasing destructive enzymes in their attempt to clean the debris of dead cells. These enzymes cause tissue damage, further increasing the inflammation and depleting these cells of their defense weaponry (enzymes). In so doing, they decrease the local area’s resistance to infection. If the body cannot rid itself of the inflammatory agents, a more chronic inflammatory condition sets in. The body tries to wall off the culprits, to protect the rest of the body, by forming granulomas and adhesions. Four fundamental signs of inflammation are: redness, heat, swelling and pain. A fifth, loss of function. is sometimes present.

An inflammatory reaction of tissues to an injury. An irritation is not an allergic response, it possesses no physiological memory of the substance that caused it. Repeated contact or long-term exposure can result in irritant contact dermatitis on the skin or chronic inflammation in a surgical wound, potentially developing into granulomas or adhesions.

An industry in which the manufacturer controls production from raw materials to finished goods.

International Organization of Standardization (ISO). A non-governmental worldwide federation of national standards bodies from nearly 130 countries. Promotes the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services. ISO Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose.

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ISO 2859

ISO 9001-9003

Isoprene A colorless, volatile liquid compound distilled from raw rubber or manufactured synthetically, used mainly to make synthetic rubber.

Sampling Procedures for Inspection by Attributes. Specifies generic attribute skip-lot sampling procedures for reducing the inspection effort on products submitted by those suppliers who have demonstrated their ability to control, in an effective manner, all facets of quality and who consistently produce lots which meet requirements as set forth by the International Organization of Standardization.

ISO 9001 represents the broadest level of quality standards defined by the International Organization of Standardization, encompassing design, manufacturing installation, and servicing systems. ISO 9002 is the same as 9001, but the company is not responsible for the design/development of the product and is used when conformance to specified requirements is to be assured by the supplier during production and installation. ISO 9003 is used when conformance to specified requirements is to be assured by the supplier solely at final inspection and test.

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Joule

Jugular Vein

JurisdictionThe power, right, or authority to interpret and apply the law; for example, Customs has the jurisdiction over all goods imported into the United States from abroad.

A joule is the amount of work done by a force of one newton acting through one meter.

Any of several veins along each side of the neck that return blood from the head.

J

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kGy

KThe International System of Units (SI) for absorbed dose where 1 gray (Gy) equals 1 joule per kilogram. This measurement of the amount of radiation exposure was formerly expressed in

megarads (Mrad) where 1kGy = 10-1 Mrad (e.g. 2.5 Mrad would now be termed 25 kGy).

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Latex

Latex Free (non-latex)

Leaching

LEAP Assay Test

Commonly, it is a milky, usually whitish fluid obtained from over 1,000 species of trees and plants. Relating to gloves, it is natural rubber latex, the raw material from the Hevea brasiliensis tree. It contains isoprene, the "rubbery" component of latex products. The latex liquid also contains the proteins (allergens) to which latex allergic (Type I) individuals react.

Containing no natural rubber latex (e.g. nitrile, vinyl, neoprene, etc.).

L atex E LISA for A ntigenic P roteins. An ELISA utilizing rabbit IgG antibodies made to latex proteins. The advantages include specificity for latex proteins and a heightened sensitivity or detection capability over the Modified Lowry assay for total protein. The disadvantage of this assay is that the latex protein allergens measured are those recognized by rabbit IgG antibodies and may or may not be recognized by human IgE. Therefore, it is basically a total protein essay and is not allergen specific. As of the printing of this document the LEAP Assay is not a valid measurement under ASTM or FDA guidelines.

A washing process commonly used during glove manufacturing to remove or denature natural water-soluble proteins and remove adverse materials such as processing chemical residues. Water, or "wet gel leaching", is the process of immersing the latex-coated formers into a bath or spray of water, to wash out excess additives from previous stages, such as coagulant. Chemical and protein content can be reduced at this stage. The effectiveness of the process is dependent on the temperature of the water, the duration of the process, and the rate of water exchange. "Dry-film" leaching is similar to the wet-film leaching, except it is carried out on the dry/vulcanised latex film. The effectiveness of this process in reducing water extractives is a function of time and temperature. Some manufacturers leach the gloves at this stage for up to 24 hours.

L

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Length

Leucocyte

Lichenification

Lining

Lot Number

Lower Detection Limit

Lowry Protein Assay

Lubrication

Lymphocyte

White blood cells, the body's major cellular defense system.

Glove length is determined by the depth of hand/arm immersion in solution, and the extent of splash protection required. To protect the hand and wrist, select a glove that is 9-14" long (23 to 36 cm). Elbow length, typically 14-18" (36 to 46 cm), protects the forearm. Shoulder length, about 31" (78 cm) gives full arm protection. Length conversion: 100mm = 1cm; 1cm = .39 in; 1 mm = .039 in.

Thickening and hardening of the skin with exaggeration of its normal markings (resembles elephant skin in appearance).

Lining, a natural or synthetic shredded fiber that covers the inside surface of an unsupported glove, offers greater hand comfort by absorbing perspiration and providing easy on and off.

Indicates where, when and by whom a specific product is made.

A test method used to determine the concentration of total protein present in a sample. A Modified Lowry assay was developed for use with latex products. In the Modified Lowry assay (ASTM D5712), latex proteins are extracted from products and purified by acid precipitation. This step diminishes the chemicals present in the product that may interfere with the assay. A protein detection agent is then added that increases in color intensity with increasing amounts of protein. Results are expressed as micrograms (_g) of total protein extracted or microgram per gram (_g/g) of sample. The greater the number, the greater the amount of protein present. This is the only method currently accepted by the government for the measure of protein level in latex products. The amount of protein on a glove generally correlates with the amount of allergen (the proteins people react to). However, not all latex proteins are allergens.

The minimum level detected with analytical test equipment, measured in parts per million (ppm) at time of breakthrough.

Hydrolysed corn starch is added as a lubricant during the manufacture of powdered gloves by tumblng the gloves in a slurry of starch and biocide.

A white blood cell, either B-cell or T-cell.

jc, rev 7-02 33


Lymphokine

Lysed

A soluble chemical released by sensitized lymphocytes on contact with a specific antigen. Lymphokines help stimulate the activity of other lymphocytes and macrophages. Lymphokines are specific forms of cytokines.

Ruptured or broken open as in lysed red blood cells during the hemolysis test.

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Maceration

Macrophage

Magnesium Oxide

Major Defects

Mast Cell

Mastication

Mediators Substances that incite, initiate or control such reactions as inflammation, white cell activation or the progress of an allergic reaction.

A very fine, white, odorless powder added to modified cornstarch to prevent caking in the production of USP absorbable dusting powder. No more than 2% is allowed.

Mast cells are white blood cells which carry receptors for IgE and together with basophils participate in immediate type hypersensitivity (Type I) reactions by releasing stored histamine and other mediators on contact with the specific allergen their IgE antibodies recognize.

A phagocytic (a cell, as a white blood cell) tissue cell that functions in the protection of the body against infection.

In processing natural rubber, the stocks first are physically and chemically masticated (shredded) before being mixed with other ingredients.

Softening of tissues by the action of a liquid, making it more vulnerable to abrasive injury. Hands can become macerated after hours of sweating under a glove, potentially resulting in irritant contact dermatitis. For workers who wear the same gloves (without removal) for hours at a time, day after day, an exaggerated or chronic form of maceration may develop with an extensive rash and painful vesicles. This condition is known as dyshydrosis. Individuals at risk include those working in cleanroom industries (e.g. semiconductors, pharmaceuticals) and in hospital housekeeping.

M

A defect that may cause the product to fail, cause poor performance, or shortened life of the unit (e.g. pinhole).

mast cells

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Meningomyelocele (Spina Bifida)

Mesophiles

Methodology

Microbe

Micrograms (_g)

Microorganisms

Micro-rough

Mil

Minor Defect

Mixed Culture

Modified Lowry Assay

Modulus

Molecular Weight

Monomer

Organisms that grow in mid-range temperatures including body temperatures.

Common term for microorganism.

A defect that is not likely to reduce materially the usability of the unit (e.g. discoloration).

Life too small to be seen without aid to the human eye.

More than one organism growing in the same culture medium.

Minute texturing on the surface of a glove, providing increased wet and dry gripping capabilities, as well as enhancing natural sensitivity.

A birth defect of the spinal column, characterized by the absence of vertebral arches (top part of the backbone), through which the spinal membranes may protrude. Thus, this portion of the central nervous system is not adequately protected. Problems experienced by the individual depend on where and how severe the defect is. They may have problems with their legs, urinary tract, etc. For reasons not totally understood, patients with Spina Bifida are at extremely high risk of developing latex-related hypersensitivity.

Measurement used for thickness of glove. Millimeters divided by 0.25 = mil. One mil = 0.001 inches = 0.025mm

See Lowry Protein Assay

A measurement of the resistance to stretch. A lower modulus represents a glove in which it is easier to move and thus less fatiguing.

A particular procedure or set of procedures; a body of rules, methods, or postulates employed by a discipline.

A chemical compound that can undergo polymerization.

The average mass of a molecule of a compound.

A unit of mass (weight) of the metric system, being one millionth of

a gram (106 gm.) or one one thousandth of a milligram (103 mg.). Used in the measurement of water extractable natural rubber latex proteins (expressed as micrograms/gram or _g/g; micrograms/milliliter or _g/ml).

jc, rev 7-02 36


MPa

MSDS Material Safety Data Sheets. They are designed to provide both workers and emergency personnel with the proper procedures for handling or working with a particular substance. Sheets include physical data, toxicity, health effects, first aid, etc. on that substance.

M egaP ascal- A unit of pressure in the meter-kilogram-second system. One megapascal equals ten bars or approximately 145.038 pounds/square inch.

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Natural Rubber Latex

NCCLS

Neoprene

Neutrophils (Polymorphonuclophils – [PMNs])

Nitrile

Non-pyrogenic

Normal Flora

Nosocomial

Bacteria that are normal inhabitants of a particular part of the body.

See Latex and Rubber

Non-fever causing. Reflects low levels of endotoxins (lipopolysaccharides) which cause fever, inflammation, endotoxic shock and elicit micro-thrombi formation (see Endotoxin ).

Infection acquired in a hospital. Nosocomial diseases may be acquired by patients, visitors or hospital staff.

See leukocytes.

N

National Council for Clinical Laboratory Standards.

A synthetic rubber developed as an oil-resistant substitute for natural rubber latex. It also resists a broad range of chemicals.

A synthetic polymer exhibiting rubber-like characteristics when vulcanized. Primary material is Acrylonitrile Butadiene, hence the name "nitrile."

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Obligate

Occupational

ONS

Organic

OSHA

Ozone

Must have the appropriate environmental factor (e.g. oxygen, temp).

Related to or derived from living organisms.

Of, or related to, a work environment.

Oncology Nurses Society. Provides support to oncology nurses and cancer patients, their families, and friends.

O

An extremely reactive gas (O3) that is produced by the interaction of oxygen and an energy source. Generators, fans, electrocautery units, X-ray machines, etc. produce ozone when running. Ozone exposure can lead to deterioration of latex and most synthetic gloves.

Occupational Safety & Health Administration. Division of US Department of Labor.

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Papules

Pathogen

Pathogenic

Permeation

Petri Dish

pH

pH Level

Phagocyte

Phagocytic

Phenolic

Pinholes

Disease producing.

Minute holes that may be present in glove film. They are often created by the presence of debris (dust, dirt, etc.) during the manufacturing process.

Cells that engulf or take in substances that the body is trying to get rid of, including bacteria, fungi, foreign bodies (e.g. asbestos) and dead cell or tissue debris.

The ability of a cell to engulf and take in foreign bodies or microorganisms. Phagocytic cells include macrophages and neutrophils (PMNs).

Movement of chemical through a glove on a molecular level. Data displaying permeation values represent breakthrough times when the glove is under continuous contact with the test chemical.

Hydrogen ion concentration; measurement of how acidic or basic a solution is.

Small circumscribed, solid, elevated bumps in the skin. Scratching them is usually painful.

Potenz power + H (hydrogen) a measure of acidity and alkalinity. A solution that is a number on a scale on which a value of 7 represents neutrality. A lower number indicates increasing acidity and higher numbers increasing alkalinity.

A specific causative agent (as a bacterium or virus) of disease.

P

Plate used to contain solid medium for microbial growth.

Any of various synthetic thermosetting resins, obtained by the reaction of phenols with simple aldehydes and used to make molded products and as coatings and adhesives. Also called phenolic resin. They are a carcinogenic risk and can cause depigmentation of the skin. 15 grams can be fatal. Brands include Citrace and Lysol. Gloves are required to handle this chemical.

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Polyurethane

Polyisoprene

Polymerization

Polymers

Polyvinyl Chloride (PVC)

Potassium Hydroxide

Powder

Preservative

Protease

An additive (e.g.. ammonia) used to protect against decay, discoloration, or spoilage.

A polyvinyl resin used extensively in the manufacture of plastics, including medical devices, such as tubing, and gloves. It is also used as a rubber substitute. See Vinyl Gloves.

A thermoplastic polymer that is the major component of natural rubber; also produced synthetically. Synthetic gloves made of polyisoprene have the same characteristics as natural rubber latex, but lack latex proteins.

Any of various synthetic resins that can become flexible or set when heated and that are used for coatings, padding, insulation, adhesives, and medical/industrial gloves.

A caustic white solid, KOH, used as a bleach and in the manufacture of soaps, dyes, alkaline batteries, and many potassium compounds. Also called caustic potash, lye, potash.

An enzyme that breaks down proteins. Present on standard gloves to varying levels, additional processing is required for its removal. Should be considered when using gloves during laboratory protein isolation and characterization studies.

Donning powder on gloves is composed of cornstarch (USP absorbable dusting powder). Some companies have qualified a lactose starch. Powder facilitates donning and absorbs sweat. Studies have shown powder to function as abrasive particles, immunological activators, and possibly as vehicles for the dissemination of chemicals, proteins and microorganisms. Powder has been implicated in lowering of resistance to infection. It also has been shown to interfere with wound healing processes, increasing the risk for incremental complications in OR and post-operative care.

A chemical compound formed by polymerization and consisting essentially of repeating structural units

The chemical union of two or more identical molecules into a larger molecule (polymer) which differs from the smaller ones (monomers) in its properties

jc, rev 7-02 41


Protein Content

Proteins

PSI

Psychrophiles

Pure Culture

Pus

Pyrogen

Pyrogenic

Organisms that grow best under cold conditions.

One organism growing in a culture medium.

Capable of eliciting a fever.

Pounds per square inch.

A "creamy" exuded matter that is the remains of necrosis of the tissues. Its main constituent is an abundance of polymorphonuclearphiles (PMN - aka neutrophile).

A fever producing substance. Endotoxin is a pyrogen.

Any of a class of naturally occurring complex combinations of amino acids (containing carbon, hydrogen, oxygen, nitrogen, usually sulfur, occasionally phosphorus) that are essential constituents of all living cells. Proteins are responsible for the growth and maintenance of all tissue. Some individuals mount an excessive IgE immunological response (allergy) when exposed to specific proteins (or similar, cross-reactive proteins). They have developed a Type I hypersensitivity to these proteins, also termed allergens.

Regarding latex gloves, protein content is the measurement of total protein regardless of allergenic content. The ASTM D5712 Modified Lowry assay is the method recognized by the government for use with gloves. Protein allergens may elicit Type I, immediate type hypersensitivity by initiating the production of IgE antibodies (that attach to mast cells). These antibodies in genetically predisposed (atopic) individuals will recognize and react with the same or similar proteins (cross-reactive proteins) in subsequent exposures. Repeated exposure to the protein allergens (or look-a-like cross-reactive allergens) through dermal, mucosal, pulmonary or invasive routes, asymptomatically (without experiencing symptoms) increases the number of sensitized mast and basophil cells until a critical threshold is reached. Once this critical threshold is attained, symptoms may occur including urticaria, rhinitis, dyspnea, abdominal cramps, headache, hypotension, tachycardia and rarely anaphylactic shock.

protein

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Quality Assurance

Quarantine To isolate from normal relations or communications, usually to prevent the spread of disease.

All those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given needs. All Sempermed gloves must meet Acceptable Quality Level (AQL) in order to be available for distribution.

Q

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Radiation

Radiation Attenuation

Radioallergosorbent Test (RAST)

Rating

Residuals

Rhinitis

RNase

Rod (Bacillus)

R

Reduces the effects of scattered or direct rays during all phases of radiation exposure (lead loaded).

The combined processes of emission, transmission, and absorption of radiant energy (in the form of waves or particles).

Inflammation of the nasal mucous membrane (runny nose).

An aftereffect that influence later behavior. Removable micron particles from finished product through scientific extraction processes

Ribonuclease. An enzyme that breaks down RNA. Present on standard gloves, additional processing is required for its removal. It is more ubiquitous than DNAse and thus more difficult to avoid. Should be considered in laboratory situations when isolating, purifying or characterizing RNA.

Rating levels developed by the American National Standards Institute (ANSI) to comply with OSHA madates for industrial gloves . Within the ANSI/ISEA 105-2000 guidelines, glove performance and pass/fail criteria are included for the following hazardous exposures: cut, puncture and abrasion resistance; protection from cold; chemical permeation and degradation; detection of holes; and heat and flame resistance. The standard also includes reference information on special considerations such as biological protection, electrical protection and radiation hazards.

Bacteria appearing elongated in shape.

A radioimmunoassay designed to detect allergens responsible for tissue hypersensitivity. The protein allergen is bound to a surface such as plastic plates or spheres. The patient’s serum is added. If the serum contains antibody to the allergen, the antibodies will attach to the allergen. The level of attachment is measured and the amount quantified. The test may be designed the other way, where the IgE antibodies are placed on the surface. Then an extract of the product, such as a glove, is added to the test to determine if allergens are present.

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RRIM

Rubber

Rubber Research Institute of Malaysia, based in Kuala Lumpur aims to make Malaysia a world center for rubber technology through its research and development activities. RRIM also ensures that the Malaysian rubber industry continues to be competitive by effectively disseminating research findings, up-to-date technology and information to the industry.

An elastic substance obtained from the latex of many tropical plants, especially Hevea brasiliensis (rubber tree). It is present in over 40,000 products in the medical and consumer industry. The term rubber more generally applies to products made from coagulated, compressed, crumbed or dried latex. Products manufactured by dipping or extruding, in which the latex is not solidified prior to processing, are more technically termed latex products. Under this definition, "rubber" products generally have lower extractable protein levels than "latex" products. Also see latex.

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SAL

SAL Dose

Sempermed

Sensitization

Sensitize

Sequela

Seroconversion

SIM

The state of being sensitized (as to an antigen) causing further irritant or medical complications.

The development of detectable antibodies in the blood directed against an infectious agent. It normally takes some time for antibodies to develop after the initial exposure to the agent. Following seroconversion, a person tests positive in tests based on the presence of antibodies (such as ELISA).

Sterilization Assurance Level. The expected probability of an item being non-sterile after exposure to a valid sterilization process.

SAL’s normally range from 10-3 (1 in a thousand) to 10-6 (1 in a million).

Society for Industrial Microbiology.

A Delaware Corporation established in May 1998. With roots dating back 175 years, Sempermed USA enjoys a long heritage of manufacturing excellence. Sempermed USA offers a full line of quality medical and industrial gloves made from latex, nitrile, vinyl, and chloroprene. Sempermed USA also maintains a dedicated sales team that provides education, sales, and technical support to both the distributor and end user. In addition to corporate headquarters in Palm Harbor Florida, Sempermed's regionalized distribution and warehousing facilities are located in New Jersey, Florida and California, providing coast-to-coast coverage and reduced order lead times.

To increase the specific sensitivity of an individual to an antigen or allergen as the result of exposure. Sensitization is asymptomatic (without symptoms) until threshold level is reached through repeated exposure. Subsequent exposure may elicit symptoms.

Adverse consequences following an event (e.g. a disease).

S

The level of radiation delivered to the product to achieve the required SAL.

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Single Wall

Size

Skin Prick Test

Slant

Smooth

Songkhla

Spina Bifida (Meningomyelocele)

Stab Culture

Stabilizer

Pronounced Sung-glue-ha , The Thai province of Songkhla is located in the southern Malay peninsula bordered by Malaysia to the south and the gulf of Thailand to the east. The city of Hatyai (Hat Yai) (prononounced HiJi ), where Sempermed product is manufactured, in located in this province.

Tube of solid medium where surface of medium get at an angle to tub opening.

Measurement criteria whereby calipers are used to produce quantitative results on a single surface thickness (e.g. only one outer surface of a glove).

A limited defect in the spinal column, characterized by the absence of vertebral arches, through which the spinal membranes may protrude. Patients with Spina Bifida are at extremely high risk of latex-related hypersensitivity. (See Meningomyelocele )

Inoculation of a solid medium is made by stabbing it with a needle to encourage anaerobic growth.

Having a continuous even surface; not textured.

A substance added to another substance or to a system to prevent or retard an unwanted alteration of a physical state.

Glove size is determined by measuring the circumference of the hand around the palm area with a tape measure. For example, if your hand circumference is 9", your closest glove size is a 9. Glove sizing varies, depending on manufacturer, origin, and style. Typically, examination gloves are sized as XS-XL and surgical gloves are sized 5.5-9.0.

This method involves extracting proteins by cutting 1 gram of latex glove into small pieces and soaking them in saline for 15 minutes. A drop of this solution is placed on a forearm, which is then pierced by a lancet, and the resulting reaction is compared to a negative control.

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Sterile

Sterilization

Sterilization Assurance Level (SAL)

Streak

Stripping

Sulfur/Sulphur

Supported

Synergistic Compunds

Synthesis

Synthetic Rubber

Systemic

Spelled "sulfur" in the U.S. and Australia, "sulphur" elsewhere. A pale yellow element that exists in various physical forms. It burns with a blue flame and a pungent smell, and is used in making matches and gunpowder. It is also a natural component of natural rubber latex.

The expected probability of an item being non-sterile after exposure to a valid sterilization process. This is a safety factor over and above demonstrating that all microorganisms are killed.

SAL’s normally range from 10-3 (1 in a thousand) to 10-6 (1 in a

million). Safeskin sterile gloves are sterilized to an SAL of 10-6.

Not of natural origin; produced by chemical synthesis. Synthetic gloves include, but are not limited to, vinyl (PVC), neoprene (chloroprene), nitrile, viton (fluorocarbon rubber), styrene

butadiene (SBR), Tactylon® (Styrene-ethylene- butylene-styrene—SEBS) and polyethylene.

High level disinfectants that have a strong odor. Kills HIV-1, TB and other pathogens of concern. These disinfectants are expensive, but highly effective. Common brands include Envirocide and Cavicide.

Method for spreading and isolating single colonies on an agar surface.

A supported glove has a fabric liner that is coated with a polymer.

The use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial spores.

The composition or combination of parts or elements so as to form a whole.

Assurance that a given device is without living organisms. The sterility assurance level (SAL) accepted by the United States (Association for the Advancement of Medical Instrumentation--

AAMI) is generally 10-6 (a probability of one non-sterile unit per million tested).

Of, or relating to, or common to a system as in affecting the body generally.

The manual or automated process of removing gloves from the formers, where they are turned inside out.

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T-Cell

Tachycardia

Tactile Sensitivity

Talc

Temperature-resistant Gloves

Tensile Strength

Textured

Thermally Activated

Thermophiles

Thickness

Titanium Dioxide

Rapid heart rate.

TiO2, white rhombic crystals that are insoluble in water and acid; used as a pigment.

Magnesium silicate, Mg3Si4O10(OH)2, is used as a solid lubricant. Itwas banned from use on surgical gloves after it was found to cause granulomas and adhesions in surgical wounds. The body treated the talc granules as foreign matter that needed to be walled off with fibrin and calcium (a.k.a. granuloma), a mechanism of protecting the rest of the body from the "invading foreign substance."

TAny of several lymphocytes (as helper T-cell) possessing highly specialized cell surface antigen receptors; immune system contributor.

The degree to which an object or substance can be discerned with the sense of touch.

Measurement of the amount of stretch or pull required to rupture or break the glove material.

The smallest of three dimensions (length, width, and thickness). Measurement of glove surface depth protecting skin from exposure to elements. Often given in mils. Conversion: 1mil = 0.001in. = 0.025mm.

The visual or tactile surface characteristics and appearance of something (e.g. a glove) represented by an uneven surface.

Made with materials designated to provide protection in extreme temperatures, such as those found in cryogenic (cold) or kiln (hot) operations.

"Body heat activated." The increase in temperature of the glove upon donning improves fit and comfort. This is particularly applicable to gloves manufactured with nitrile and vinyl.

Organisms that grow best under hot conditions.

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T-lymphocyte

Type I Hypersensitivity (Protein Allergy)

Type IV Hypersensitivity (Chemical Allergy)

An IgE-mediated immediate hypersensitivity reaction, characterized by contact urticaria (hives), angioedema, rhinitis, respiratory complications, drop in blood pressure and rapid heart rate which may potentially progress to anaphylaxis. Severe cases may be fatal. Examples include Type I allergies to: penicillin, peanuts, strawberries, bee stings and natural rubber latex proteins.

A cell-mediated delayed hypersensitivity reaction, characterized by dermatitis, eczema, erythema, vesiculation (blisters), keratosis, hyperplasty (thickening of skin) and cracking. The area affected usually increases with repeated exposure. Examples include Type IV allergies to: poison oak, nickel, soaps and fragrances.

The lymphocyte responsible for cell-mediated immunity. When sensitized, T-lymphocytes have a receptor that recognizes a specific chemical antigen (chemical sensitizer). On subsequent exposure to that chemical, the sensitized T-cell releases lymphokines, which attract macrophages, neutrophils and other white blood cells to the reaction site. Inflammation ensues and can become chronic. This condition, Type IV hypersensitivity, is also know as allergic contact dermatitis, delayed hypersensitivity or chemical allergy.

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ug/g

Universal Precautions

UPC

Urticaria

USP

Micrograms per gram. More accurately shown as _g/g (not the letter "u"). Used in the measurement of water extractable natural

rubber latex proteins. Protein tests also provide results as _g/dm2

(micrograms of protein per square decimeter surface area of glove film) or _g/glove (micrograms of protein per one glove).

Universal Product Code. Uses bar code technology for automated product identification and inventory control. See HBIC.

United States Pharmacopeia. A non-profit organization founded to develop quality standards for drugs. Also maintains drug and medical information database used by healthcare professionals.

A method of infection control in which all human blood and certain other potentially infectious materials are considered infectious for HIV, HBV, and other bloodborne pathogens. It encompasses a variety of practices to prevent occupational exposure, such as the use of personal protective equipment, proper disposal of sharps, housekeeping and so forth.

Ur-ti-car-ia: an allergic disorder marked by raised edematous patches of skin or mucous membrane and intense itching caused by contact with a specific precipitating factor. Hives.

U

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Vasoactive Substance

Vesicle

Viable

Vinyl Gloves

Viscosity

Viral

Viral Penetration

Virus

Volatile

V-tear

Vulcanization

Rapidly vaporizable at a relatively low temperature. Characterized by or subject to rapid or unexpected change.

Usually refers to polyvinyl chloride (PVC). Resin used as a rubber substitute in many medical and industrial applications. Although the material itself is a barrier to microorganisms, its non-elastic properties do not allow for maintenance of barrier integrity after extended use, or in rigorous procedures.

Substances that act on blood vessels; for example, to dilate (expand), constrict or alter blood vessel permeability.

Capable of living, growing or developing as an independent unit.

Obligate intracellular parasites of living, but noncellular nature, consisting of DNA or RNA and a protein coat. They range in diameter from 20-300nm.

A small circumscribed elevation of the epidermis containing a serous fluid; a small blister.

Measurement of the amount of weight necessary to propagate a tear.

Vulcanization was one of the key discoveries in the manufacture of rubber products. Chemical agents such as sulfur are used to create strong chemical cross-links between the intertwined polymers of some rubbers. This chemical transformation results in a network structure far stronger and more elastic than that of the starting (raw) material.

The varied thickness of a solution, chemical or liquid product in any state during the mixing, compounding and formulation process.

Relating to, or as a result of a virus.

The ability of a virus to pass through something.

V

virus

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Water Extractable Proteins

Water Leaching

Water Leak Test

Water Soluble

Weight

Wet Donning

Wheal

White Cell

Width

Capable of being loosened or dissolved in water.

The cells of the immune system; also called leukocytes. They received the name white cells because they compose the thin white layer that forms on top of the red blood cells when blood is spun in a centrifuge. See leukocytes .

A circumscribed swelling of the skin, appearing as an urticarial (hive) lesion; slightly reddened, often blanched in the center, changing in size and shape, extending to adjacent areas, and usually accompanied by intense itching; produced by exposure to Type I allergenic substances in susceptible persons.

The measurable amount of proteins, given in terms of micrograms or milligrams, produced by water extraction on natural rubber latex gloves. ASTM D5712 provides an analytical test for determining the amount of total water extractable protein associated with natural rubber and its products. The test method involves an extraction and precipitation procedure followed by an assay of protein content (Modified Lowry Protein Assay).

W

A test procedure recognized under ASTM D5151 and FDA protocols to determine the AQL level of an exam glove. The latex glove is filled with a prescribed amount of water (1000ml) and must remain completely leak-proof over a defined period of time.

To put on when you are wet.

See Leaching.

Dimensional measurement. For gloves usually measured across the palm, from just above the thumb to just below the small finger.

For gloves usually given in grams. Average glove weight is 9 to 14 grams.

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X-irradiation

X-radiation

X-ray

X-radiation (x-ray).

Exposure to x-rays.

Any of the electromagnetic radiations of the same nature as visible radiation, but having an extremely short wavelength of less than 100 angstroms, that is produced by bombarding a metallic target with fast electrons in vacuum or by transition of atoms to lower energy states and that has the properties of ionizing a gas upon passage through it.

X

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Yield To bear or bring forth as a natural product especially as a result of cultivation (rubber trees yield resin used in the production of natural rubber latex gloves).

Y

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Zinc Chloride

Zinc Oxide An infusible white solid, ZnO, used especially as a pigment in compounding rubber, and in pharmaceutical and cosmetic preparation.

ZA poisonous caustic deliquescent (tending to melt or dissolve) salt, ZnCl, used especially as a preservative, drying agent, and catalyst.

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Typical Latex Glove Manufacturing Process

Harvesting of Latex

Addition of Preservative

Centrifugation

Compounding

Dipping & Coagulation

Wet-Gel Leaching

VulcanizationStripping

Dry-Film Leaching

Drying

Lubrication/Chlorination

Checking/Quality Assurance

Packaging

Sterilization (if applicable)

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PSI =MPa =

l =ml =

Au =g or gr =

mg =ng =pg =

µg =ppm =

Millimeters (mm) =

Strength :Length :

Thickness :

Avg. weight of a glove :

Prefix Symbol Powertera T 1012giga G 109

mega M 106kilo k 103

hecto h 102deca da 101unitydeci d 1-Octcenti c 2-Octmilli m 3-Oct

micro m 6-Octnano n 9-Octpico p 12-Oct

femto f 15-Octatto a 18-Oct

0.01

0.000001

0.000000000000001

0.0000000010.000000000001

0.000000000000000001

milligramsnanogramspicogramsmicrograms

milliliters

10.1

Weight per gram of device : 1 ppm = 1mg/g = 1,000ng/g = 1,000,000pg/g = .001mg/g

0.001

10

1,000,000,000

Multiple 1,000,000,000,000

1,000,0001,000100

part(s) per million

0.039 inches

9 to 14 grams

1 MPa = 145 PSI1 mm = 0.039 inches1 mil = 0.001 inches = 0.025 mm

Allergen unitsgram

Pounds per square inchMega Pascals

liter

Abbreviations/Conversions

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glossary of terms applicable to the medical and … · abcess absorbable dusting ... a condition of...

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