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A powder free patient examination glove is a disposable device made of latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.

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This document describes the FDA's decision to allow the marketing of "Green Peppermint Flavored Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or less)". It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter assesses substantial equivalence of the gloves to previously marketed devices, which is a regulatory standard, not a performance study as would be conducted for a new diagnostic or therapeutic AI device.

Therefore, I cannot provide the requested information based on the provided text. The document is an FDA 510(k) clearance letter for examination gloves, which falls under general controls and does not involve AI or complex performance studies like those relevant to the questions asked.

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