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Product Name Non-sterile Powder Free Polymer Coated Latex Examination Gloves
Thickness 4.7 MIL
Average Weight of Medium Size 6.2 gm (± 0.2gm)
Usage To conduct medical examination, diagnostic and therapeutic procedures to protect patient and user from cross contamination or infection.
Material Natural Rubber Latex Compound
Cuff Finishing Beaded
Color Natural
Type Ambidextrous
Surface finish Textured
Product Characteristic:
Dimension
Size
Palm Width (mm) Length (mm)
X-Small 80 ± 5mm 240min
Small 85 ± 5mm 240min
Medium 95 ± 5mm 240min
Large 106 ± 5mm 240min
Extra Large 115 ± 5mm 240min
Thickness Single wall thickness (mm)
Cuff 0.08 - 0.11
Palm 0.11 - 0.14
Finger 0.11 - 0.17
Physical Properties   Un-aged Aged
Tensile Strength (MPa) 19 - 23 16 - 22
Ultimate Elongation (%) 700 - 820 650 - 750
Stress at 500% (MPa) 3 - 5 -
Physical Properties (EN Standard)   Un-aged Aged
Force at break (N) Min 9 Min 6
Residual Powder 2.0 mg/glove maximum
Protein Content Max 50µg/dm2
    In-House Standard EN Standard

Quality Specification

* AND – Accept No Defects
* n - number of samples

Inspection Criteria Sampling Plan/AQL Sampling Plan/AQL
Dimension S2 – AQL 4.0 13 pcs (Median)
Physical Properties S2 – AQL 4.0 -
Force at Break - 13 pcs (Median)
Water Tight Test G1 – AQL 1.0 G1 - AQL 1.5
GII – AQL 1.5 Multiple
Visual Inspection – Major G1 – AQL 2.5 G1 – AQL 2.5
Visual Inspection – Minor G1 – AQL 4.0 G1 – AQL 4.0
Residual Powder n = 5 (average) n = 5 (average)
Protein Content n = 3 (average) n = 3 (average)
Packaging labeling n = 5 (AND) n = 5 (AND)
Glove Physical Counting n = 5 (AND) n = 5 (AND)
Packaging Configuration and Labeling:
Packing 100 / 200 Gloves per Inner Dispenser (by weight)
10 / 20 Dispensers per Outer Carton
Labeling The dispensers and outer cartons shall have the following information/prints:
Product description and Brand including size and net quantity of gloves.
Name and Country of Origin of Manufacturer or Distributor.
Single Use Only or the Symbol for single use.
Non-sterile and Caution Statement on possible allergic reactions.
Lot Numbering System Per the customer’s requirement or in house as per packing SOP.
Manufacturing and/or expiry date where applicable.
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