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A 510 k clearance is mandatory for examination and surgical gloves to market in the USA. FDA review time for a 510 k notification is 3 months, but in reality, it may take 6 months or more depends how perfect your 510k documentation is. FDA published guidance documents for latex and nitrile (examination and surgical) gloves 510k submission.

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Jul 01, 2021·Also called nitrile exam gloves, the medical-grade protective gloves made of nitrile material perfectly suit those industries that might expose you to environmental contaminants and blood-borne pathogens. With this, you will most likely see the medical-grade or exam nitrile gloves in dental and medical offices, laboratories, and hospitals.

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