henry schein inc henry schein services gmbh (ec rep)

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Customer Brand Material Appearance Thickness & Colour Surface Dimension Thickness- reference data Weight- reference data Physical Properties Powder Residue : Contains less than 2 mg per glove. Design Feature : Ambidextrous, straight fingers, smooth and beaded cuff. Product Conformance : Conform to ASTM D6319,EN 455 -1,2,3 and 4, EN 374 -1,2 In compliance with European Medical Device Directive 93/42/EEC (CE Class 1). Process : Donning area : Online Chlorination Working area : Polymer coated Packing : 50 gloves per dispenser box and 10 dispensers per carton. Shelf Life : 3 years Pre-shipment Quality Assurance : Manufacturing process in compliance with ISO 9001 & ISO 13485 Quality 9880158 17/9/2014 31/3/2020 1 Visual Inspection for Minor Defects Inspection Criteria Dimension Point of Thickness Measurements Finger (at 15mm from the extreme tip) Visual Inspection for Major Defects Force at Break (N) Physical Properties 1000 ml Water Leak Test Criteria Tensile Strength (MPa) Palm (at center of palm) Elongation (%) Palm Width (mm) Length (mm) Extra-Small 70 - 81 400 (min.) Size Small 81 - 90 400 (min.) 100 - 110 400 (min.) Medium 90 - 100 400 (min.) Extra-Large 110 - 120 Large Before Aging After Aging 14 Note: * Spec refer to Min Thickness 400 (min.) 2.5 4.0 G-1 G-1 Henry Schein Inc / Henry Schein Services GmbH (EC REP) BLUE NITRILE EXAMINATION GLOVE 500 (min.) 13 G-1 ≥ 6 14 400 (min.) ≥ 6 AQL Median value must comply : 6.0 mil Blue, Long Cuff Note: The data in above tables represent typical analyses of the glove at time of publication and not to be used as actual product specifications. Median value must comply 1.5 Inspection Level 13 Product Data Sheet Doc No : Date : Rev Date : Rev No : : Smooth : Henry Schein Nitrile Blue Extended Cuff : 100% Nitrile (Acrylonnitrile-butadiene) : Powder free, non-sterile Medium (size) Single Wall(mm) 0.17-0.28* 0.14-0.18* 14.0-15.0g Weight(g) (For reference only) Henry Schein Inc. 135 Duryea Road, Melville, NY 11747 USA EC Rep: Henry Schein Services GmbH, Monzastrasse 2a, 63225 Langen, Germany www.henryschein.com Henry Schein Item Code 9880158 9880159 9880160 9880161 9880162

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Page 1: Henry Schein Inc Henry Schein Services GmbH (EC REP)

Customer Brand

Material

Appearance

Thickness & Colour

Surface

Dimension

Thickness- reference data

Weight- reference data

Physical Properties

Powder Residue : Contains less than 2 mg per glove.

Design Feature : Ambidextrous, straight fingers, smooth and beaded cuff.

Product Conformance : Conform to ASTM D6319,EN 455 -1,2,3 and 4, EN 374 -1,2

In compliance with European Medical Device Directive 93/42/EEC (CE Class 1).

Process : Donning area : Online Chlorination

Working area : Polymer coated

Packing : 50 gloves per dispenser box and 10 dispensers per carton.

Shelf Life : 3 years

Pre-shipment

Quality Assurance : Manufacturing process in compliance with ISO 9001 & ISO 13485 Quality

pproved By988015817/9/201431/3/2020

1

Visual Inspection for Minor Defects

Inspection Criteria

Dimension

Point of Thickness Measurements

Finger (at 15mm from the extreme tip)

Visual Inspection for Major Defects

Force at Break (N)

Physical Properties

1000 ml Water Leak Test

Criteria

Tensile Strength (MPa)

Palm (at center of palm)

Elongation (%)

Palm Width (mm) Length (mm)

Extra-Small 70 - 81 400 (min.)

Size

Small 81 - 90 400 (min.)

100 - 110 400 (min.)

Medium 90 - 100 400 (min.)

Extra-Large 110 - 120

Large

Before Aging After Aging

≥ 14

Note: * Spec refer to Min Thickness

400 (min.)

2.5

4.0

G-1

G-1

Henry Schein Inc / Henry Schein Services GmbH (EC REP)

BLUE NITRILE EXAMINATION GLOVE

500 (min.)

13

G-1

≥ 6

≥ 14400 (min.)

≥ 6

AQL

Median value must comply

: 6.0 mil Blue, Long Cuff

Note: The data in above tables represent typical analyses of the glove at time of publication and not to be used as actual product specifications.

Median value must comply

1.5

Inspection Level

13

Product Data Sheet

Doc No :Date :Rev Date :Rev No :

: Smooth

: Henry Schein Nitrile Blue Extended Cuff

: 100% Nitrile (Acrylonnitrile-butadiene)

: Powder free, non-sterile

Medium (size)

Single Wall(mm)

0.17-0.28*

0.14-0.18*

14.0-15.0g

Weight(g) (For reference only)

Henry Schein Inc. 135 Duryea Road, Melville, NY 11747 USAEC Rep: Henry Schein Services GmbH, Monzastrasse 2a, 63225 Langen, Germany

www.henryschein.com

Henry Schein Item Code

9880158

9880159

9880160

9880161

9880162