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Brightway™ Brand Colored Nitrile Examination Glove (Powder Free is a disposable patient examination glove which is worn on the hand o healthcare and similar personnel to prevent contamination between patient and examiner.

Brightway™ Brand Colored Nitrile Examination Gloves (Powder Free)

The provided text is a 510(k) premarket notification letter from the FDA regarding "Brightway™ Brand Blue Nitrile Examination Gloves Powder-Free". This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

Instead, it is a regulatory document stating that the FDA has determined the device to be substantially equivalent to devices marketed prior to May 28, 1976. It outlines the general controls provisions of the Act that the manufacturer must adhere to, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested information.

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