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A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

POWDER FREE NITRILE (DARK BLUE ) EXAMINATION GLOVES

This document is an FDA 510(k) clearance letter for Powder Free Nitrile (Dark Blue) Examination Gloves. It does not contain information about the acceptance criteria and study proving a device meets those criteria in the way described in your request (i.e., for an AI/CAD medical device or a diagnostic test).

The provided text focuses on regulatory approval for examination gloves and mentions basic regulatory requirements. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, ground truth details, or expert qualifications.
• Information about multi-reader multi-case studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot fulfill your request using the information present in these documents. The document is a regulatory approval for a class I medical device (patient examination glove), which typically involves compliance with standards like ASTM for physical properties (e.g., tensile strength, elongation, barrier integrity like pinholes), not the detailed performance metrics you've asked for related to AI or diagnostic device studies.

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