Henry Schein Inc Henry Schein Services GmbH (EC REP)
Transcript of 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