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The Biodegradable Nitrile Powder Free Examination Glove (Blue) is a non-sterile disposable device intended for medical purpose that is worn on examinet's hand to prevent contamination between patient and examiner.

Biodegradable Nitrile Powder Free Examination Glove (Blue)

This document is a 510(k) premarket notification letter from the FDA regarding a Biodegradable Nitrile Powder Free Examination Glove (Blue). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It primarily deals with the regulatory classification, general controls, and other administrative information for getting the device approved for marketing.

Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria and a study proving the device meets those criteria.

This type of information is typically found in the 510(k) summary or detailed test reports, which are not part of this specific letter.

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