bodyguards gl891 long nitrile examination gloves · bodyguards® gl891 long nitrile examination...

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Bodyguards ® GL891 Long Nitrile Examination Gloves Product Type: Powder free Nitrile examination gloves, long. Size Small Medium Large X-Large Product Code GL8911 GL8912 GL8913 GL8915 NHS Code FTE1186 FTE1187 FTE1188 FTE1189 Gloves Specification: Material: Nitrile Surface Finish: Finger textured Colour: Blue Design: Ambidextrous, Latex free. Beaded cuff for extra strength and easier donning. Strong, soft and flexible. Latex Free: Yes Packaging: Dispenser: 100 gloves per dispenser box Outer Case: 10 dispensers per case Pallet: 36 cases per pallet Performance Specification: Freedom from holes - BS EN 455-1 Water Tight Test General Inspection Level 1, AQL 1.5 Dimensions – BS EN 455-2 Small Medium Large X-Large Palm Width (mm) 80 ± 10 95 ± 10 110 10 110 Length (mm) 290 min 290 min 290 min 290 min Force at Break – BS EN 455-2 Throughout shelf life Minimum 6 Newton After challenge test Minimum 6 Newton Biological Properties – BS EN 455-3 Powder Level Less than 2 mg per glove Protein Content (Latex only) 50 g/g using the modified Lowry method Viral Penetration – ASTM F1671-7 Phi-X174 Bacteriophage penetration No visual penetration Shelf Life Properties – BS EN 455-4 Currently shelf life is determined through accelerated ageing and is set at 3 years (whilst real time studies are in progress) Protective gloves against chemicals and micro organisms - BS EN 374 Resistance to penetration Waterproof gloves and low chemical protection Resistance to penetration Micro organism resistant as defined in EN374-1 Quality Standards: Manufacturing QMS EN ISO 9001 / EN ISO 13485 Glove The BS EN 455 series of standards (parts 1,2,3 and 4) Sampling & Inspection ISO2859-1 MDD Requirement Medical Devices Directive 93/42/EEC (and subsequent amendments) PPE Requirement Personal protective equipment directive 89/686/EEC CE Classification Class I non-sterile Medical Device CE Classification Complex Design, category III

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Page 1: Bodyguards GL891 Long Nitrile Examination Gloves · Bodyguards® GL891 Long Nitrile Examination Gloves Product Type: Powder free Nitrile examination gloves, long. Size Small Medium

Bodyguards® GL891Long Nitrile Examination Gloves

Product Type:Powder free Nitrile examination gloves, long.

Size Small Medium Large X-LargeProduct Code GL8911 GL8912 GL8913 GL8915NHS Code FTE1186 FTE1187 FTE1188 FTE1189

Gloves Specification:Material: NitrileSurface Finish: Finger texturedColour: BlueDesign: Ambidextrous, Latex free. Beaded cuff for extra strengthand easier donning. Strong, soft and flexible.Latex Free: Yes

Packaging:Dispenser: 100 gloves per dispenser boxOuter Case: 10 dispensers per casePallet: 36 cases per pallet

Performance Specification:Freedom from holes - BS EN 455-1Water Tight Test General Inspection Level 1, AQL 1.5

Dimensions – BS EN 455-2 Small Medium Large X-Large Palm Width (mm) 80 ± 10 95 ± 10 110 ≥ 10 ≥ 110Length (mm) 290 min 290 min 290 min 290 min

Force at Break – BS EN 455-2Throughout shelf life Minimum 6 NewtonAfter challenge test Minimum 6 Newton

Biological Properties – BS EN 455-3Powder Level Less than 2 mg per gloveProtein Content (Latex only) ≤50 g/g using the modified Lowry method

Viral Penetration – ASTM F1671-7Phi-X174 Bacteriophage penetration No visual penetration

Shelf Life Properties – BS EN 455-4Currently shelf life is determined through accelerated ageing and is set at 3 years (whilst real time studies are in progress)

Protective gloves against chemicals and micro organisms - BS EN 374

Resistance to penetration Waterproof gloves and low chemical protectionResistance to penetration Micro organism resistant as defined in EN374-1

Quality Standards:Manufacturing QMS EN ISO 9001 / EN ISO 13485Glove The BS EN 455 series of standards (parts 1,2,3 and 4)Sampling & Inspection ISO2859-1MDD Requirement Medical Devices Directive 93/42/EEC (and subsequent amendments)PPE Requirement Personal protective equipment directive 89/686/EECCE Classification Class I non-sterile Medical DeviceCE Classification Complex Design, category III

Page 2: Bodyguards GL891 Long Nitrile Examination Gloves · Bodyguards® GL891 Long Nitrile Examination Gloves Product Type: Powder free Nitrile examination gloves, long. Size Small Medium

Packaging Artwork:

Inner Outer

Barcodes:

Size Small Medium Large X-Large

Inner 5010699525901 5010699525918 5010699525925 5010699525932

Outer 5010699834980 5010699834997 5010699835000 5010699835017

Packaging Symbols:

g Lot number LATEX Latex free5:l25:

Temperature limitation

N Date of manufacture Powder free Recyclable

packaging

H Use by Acceptable quality level p Keep dry

M ManufacturerCompliant with protective gloves general requirements

w Keep away from sunlight

Compliant with the Medical Devices Directive

Protection against chemical hazards

Compliant with the Personal Protective Equipment Directive

Protection against micro-organism and biological hazards

d Non sterile

D Single use - do not re-use

Bodyguards® GL891Long Nitrile Examination Gloves

GL891/APRIL 2016

POWDER

Class IMedicalDevice

0088

EN374 - 3: 2003

EN374-2:2003

F

Dimensions: Dispenser: L270mm x W135mm x H80mm Outer: L410mm X W280mm X H280mm

HealthlineColwood House, 158 Garth Road, Morden, Surrey, SM4 4LZ England

020 8335 5213 (Office)

020 8335 5252

[email protected]

www.healthline.co.uk