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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Comfort Powderfree Latex Examination Glove with Latex ("Powder-free") 80LYY Protein Content Labeling Claim (50 micrograms or less)

The provided document is a 510(k) premarket notification letter from the FDA regarding "Comfort Powder-Free Latex Examination Gloves." This document grants substantial equivalence to a medical device, which is a regulatory approval, not a scientific study describing acceptance criteria and device performance based on a study.

Therefore, the document does not contain any of the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance), or training set information. The document solely focuses on regulatory approval based on substantial equivalence to a predicate device.

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