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This glove is disposable and intended for surgical purpose that is worn on the surgeon's hand to prevent contamination between patient and surgeon.

Sterile Nitrile Surgical Gloves (Powdered)

The provided text is a 510(k) premarket notification letter from the FDA regarding "Sterile Nitrile Surgical Gloves (Powdered)". This document is a regulatory approval letter and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in the 510(k) submission, which would have included data to demonstrate substantial equivalence, but the specifics of that data are not present in this letter.

Therefore, I cannot provide the requested information based on the given text.

To answer your questions, I would need access to the full 510(k) submission document or a summary thereof, which would detail the performance data, acceptance criteria, study design, and methodology used to demonstrate the substantial equivalence of the Sterile Nitrile Surgical Gloves.

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