disposable examination gloves

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Disposable Examination Gloves

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Page 1: Disposable Examination Gloves

Disposable Examination Gloves

Page 2: Disposable Examination Gloves

Disposable Nitrile Examination Gloves

Flexible & Ductile

Straight Fingers

Polymer Coated

Powder Free Textured Finger tips

Ambidextrous

Latex Free

Non-Sterile

NON STERILE

LATEXFREE

365 Inter Gloves™

Page 3: Disposable Examination Gloves

Product and Specifications365 Inter Gloves™

Commodity

Quality

Size

Storage

Shelf-life

Packaging

Nitrile Gloves - Powder Free - Textured finger tips

CE by EU notified bodyEN 455 (1,2,3,4)EN 420EN 374 (1,3,4,5)US FDA ASTM 6319AQL ≤1.5

Size breakdown to be requested by client in the SPA. Standard breakdown: S-M-L-XL (10%-30%-50%-10%)

Store in a dry and cool place, the temperature not higher then 38°C

3 years from the date of manufacturing

100 pcs. by weight per box.10 boxes per carton.3000 cartons per container (40" HQ)

Page 4: Disposable Examination Gloves

Disposable Nitrile Examination Gloves

Type

Glove Length (mm)

Palm Thickness (mm)

Palm Width (mm)

Finger Thickness (mm)

Powder Residue (mg)

Freedom from Holes

Proteins extraction

Determination of pH Value, pH Value

Weight (glove)

≥ 240

≥ 0.1

83-85ASTM D6319-19;

Clause 7.4, ASTM D3767-3:2020

EN 455-2:2015

ASTM D6319-19; Clause 7.6

ASTM D6124-06:2017

0.12 ± 0.03

Requirement 2.0

Requirement AQL 1.5

MDL 3 μg/g

Requirement > 3.5 & < 9.5

3.8 ± 0.3

92-95

0.12 ± 0.03

Test Result 1.7

Test Result AQL 1.5

Test Result Not Detected

Test Result 8.5

4.3 ± 0.3

103-106

0.12 ± 0.03

4.7 ± 0.3

112-115

0.12 ± 0.03

5.0 ± 0.3

EN 455-1:2000

EN 455-3:2015

BS EN ISO 21420:2020

Material

Design

Packing Size

Carton Size

Colors

Shelf Life

Classification

Usage

Content

Content

Texture

Storage

Distributed by

Physical Specification

Physical Properties

Bygmestervej 6, 2400 Copenhagen NV, Denmark - Tel +45 35367516

Polymer Coated Powder free Examination Gloves

Acrylonitrile Butadiene Copolymer (NBR)

Ambidextrous; beaded cuff

11cm x 6.7cm x 21.6cm

23cm x 35cm x 23cm

Blue (ASTM D573-04:2019)

3 Years

Class I (FDA) // PPE Cat III

Disposable, Single Use Only

100 gloves per box (by weight)

10 boxes per carton

Smooth/Textured

Between 10°–40°C (50°–104°F)

STIELER & CO

Values Small Medium Large Extra Large Meet Standard

Page 5: Disposable Examination Gloves

Disposable Nitrile Examination Gloves

Sizing, minimum length of glove (mm), Size M

Dexterity, level of performance

Requirement 240 Test Result 240 ± 5 BS EN ISO 21420:2020

BS EN ISO 21420:2020

Smallest pin diameter fulfilling test conditions11 mm9.5 mm8 mm

6.5 mm5 mm

12345

Test Result 5

Product Specifications

Values Standard & Result

Before Aging (N) After Accelerated Aging (N)(70°C for 166 hours)

Meet Standard

Tensile Strength (MPa)

Food Grade

Elongation at Break (%)

Reflux Temperature for 7 hours

Reflux Temperature for 7 hours

Succeeding 2 hours of extraction

Succeeding 2 hours of extraction

For use in contact with aqueous foods

For use in contact with fatty foods

Median Force at Brake

Extractants: Distilled Water

Extractants: n-Hexane

Food Grade

Global Migration from Rubber

40.5

US (United State of America) & EU (Europe)

630

0.1mg/inch2

0.1mg/inch2

0.1mg/inch2

0.1mg/inch2

8.57

RL (Denote Reporting Limit)

RL (Denote Reporting Limit)

EU (Europe)

The migratory behaviour is examined in accordance with Directive 82/711/EEC and Council Directive 85/572/EEC and its corresponding regulations. Deviatine to the

regulations the following tests were performed as orientating single test.

For PPE cat III Personal Protective Equipment, Regulation(EU) 2016/425

EN 455-1,2,3,4 EN 1186

US FDA Food Contact

ASTM D6124

EN 374-1,3,4,5

ASTM D412-16 ASTM D573-04:2019

ASTM D6319-19

35.0

620

0.7mg/inch2

0.3mg/inch2

Not detected

Not detected

20mg/inch2

175mg/inch2

1mg/inch2

4mg/inch2

8.72

Result

Result

Permissible Limit

Permissible Limit

EN 455-2:2015

US FDA 21 CFR 177.2600 (Rubber Articles)

US FDA 21 CFR 177.2600 (Rubber Articles)

EN 1186

ASTM D6319-19; Clause 7.5 &

ASTM D573-04:2019

Values Standard & Result Meet Standard

Quality Standard

ASTMASTM ASTM

ASTM

D 6124D 412-16 D 573-04

D 6319-19