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

Powder Free Latex Patient Examination Gloves

The provided text describes a 510(k) premarket notification for "Powder Free Latex Patient Examination Gloves". This document is a regulatory approval letter from the FDA, not a study evaluating the performance or acceptance criteria of an AI or medical device with specific performance metrics.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because the document does not contain this type of data. It is a regulatory approval for a physical product (gloves) based on substantial equivalence, not a performance study of a device against specific clinical or technical metrics.

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