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A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim ( 50 Micrograms or Less )

I am sorry, but based on the provided document, I cannot extract the information required to answer your request. The document is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Multi-Ply Latex Examination Gloves With Protein Labeling Claim (50 Micrograms or Less)."

This document primarily focuses on the regulatory approval of a medical device (examination gloves) and does not contain details about:

• Acceptance criteria and reported device performance in a table format.
• Specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Adjudication methods or multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance or training set details.

The document is a letter confirming substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices, rather than a detailed study report.

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