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A powder-free sterile surgeon's glove is a disposable device made of Non-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.

Non-latex sterile powder-free surgeon's glove

I'm sorry, but this document does not contain the information requested. This document is a 510(k) clearance letter from the FDA for a non-latex sterile powder-free surgeon's glove. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not include details about:

• Acceptance criteria and reported device performance related to a study.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Any information regarding a multi-reader, multi-case study or standalone algorithm performance.
• Training set details for an algorithm.

This document is a regulatory approval, not a scientific study report.

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