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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

OmniGrace Latex Examination Glove, Powdered, with Protein Claim (100 Micrograms or Less)

This document is a marketing clearance letter from the FDA for a medical device, specifically, the OmniGrace Latex Examination Glove. It does not contain information about acceptance criteria or a study proving device performance as it is primarily concerned with regulatory clearance rather than a technical performance report.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment from the provided text.

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