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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.

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.

This document is a 510(k) clearance letter from the FDA for a medical device: "BIOGEL Latex Sterile Powder-Free Surgeon's Glove." It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-enabled medical device.

This document is a regulatory approval for a physical medical device (gloves), confirming its substantial equivalence to a predicate device. The information requested (Table of acceptance criteria and device performance; sample sizes, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.) is specific to the evaluation of AI/ML software.

Therefore, I cannot provide the requested information based on the provided text.

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