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Fda regulate latex and nitrile gloves examination and surgical as medical devices. Even though the gloves are class 1 device it requires fda 510k clearance medical device establishment registration and device listing to market in the usa powdered gloves are not allowed to market in the usa for medical purpose. The fda also does not have a list of gloves suppliers. They are in conover nc.

Fda requires manufacturers to identify on the package labeling the materials used to make the gloves. If you or your patient is allergic to natural rubber latex you should choose gloves made from.

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