Nitrile Powder Free, Textured, 9” length, dark blue, 5.0 G., for Examination Use
10 Boxes of 100 per Case
We hereby inform that we are in compliance with the 510(K) clearance provisions of the U.S. Food and Drug Administration (FDA), who is authorized, regulates products with direct contact with food by Congress under The United States Federal Food, Drug, and Cosmetic Act (FFDCA). All ingredients used in the production of our gloves comply with Food Contact Materials standard. All ingredients are considered to be generally recognized as safe for use in food handling.
In addition to that, our entire medical examination gloves meet or exceed all regulations set by the Food and Drug Administration (FDA) for safe use in general medical applications.
Physical Requirements:
Before Aging: Tensile Strength: 15 MPA (min); Elongation: 500% (min)
After Accelerated Aging: Tensile Strength: 14 MPA (min); Elongation: 400% (min) 4.0 5.0
Freedom from holes: According to ISO 2859, G-II, multiple sampling plan for normal
inspection, AQL 1.5
Powder Residues: For Pre-powdered gloves, not more than 10mg/dm ; for powder free
gloves, not more than 2mg per glove.
Chemex Industries, Inc.
3 Chattanooga
Irvine, CA 92620
Fax: 714-832-8103
barry@chemexindustries.com
Office: 714-832-8441
Toll Free: 866-938-7657
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