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A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.

A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.

The provided document is a 510(k) clearance letter from the FDA for medical gloves. This type of document declares that a device is substantially equivalent to a predicate device already on the market. It does not contain information about formal acceptance criteria, device performance studies, sample sizes, expert ground truthing, or multi-reader multi-case studies, which are typically found in detailed technical reports or clinical study summaries.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results.

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