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A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Biogel Latex Sterile Powder-Free Surgeon's Glove with Low Dermatitis Potential and Protein Content Labeling Claim (50 micrograms or less)

I apologize, but the provided text only contains a 510(k) clearance letter from the FDA for a surgeon's glove. It does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. This document is a regulatory approval notice, not a technical report detailing the device's validation.

Therefore, I cannot extract the requested information from the given input.

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