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Biocompatibility testing's are mandatory sections in FDA 510k submission for examination and surgical gloves, most of the cases these tests are conducted on a third-party lab. Besides the biocompatibility testing , the below in-house tests are also required in 510k notification and test results must comply with approved standards like ASTM and ISO.

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Nitrile Examination Gloves (Powder Free, Latex Free) Type: Powder-Free, Non-Sterile. Material: Nitrile Butadiene Rubber (NBR) - Latex Free. Colors : Blue, White. Design & Features: Ambidextrous, beaded cuff, fingertip textured and non-sterile. Storage : The Gloves shall maintain their properties when stored in dry condition.

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For medical gloves, i.e., patient examination gloves and surgeon’s health care providers may wish to consider these strategies and risk mitigations based on the supply levels of their health ...

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Long Cuff Powder-Free Nitrile Gloves (50/box) Close. Hot. Long Cuff Powder-Free Nitrile Gloves (50/box) ... 510K/Approved for medical use (exam) ISO 9001 Certified QMS; Gloves come 50/box; Glove Size: Order No. ... Sirchitize Hand Sanitizer, 1 gallon. $39.95. KN95 Disposable Surgical Masks, 50 each. $199.95. Related Products. Check items to add ...

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