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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE VELLOW

This document is an FDA 510(k) clearance letter for "Synthetic Vinyl Patient Exam Gloves Powder-Free Yellow." It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them because the provided text does not contain this information.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the gloves to legally marketed predicate devices.
• Regulatory requirements for marketing the device.
• The intended use of the patient examination gloves (preventing contamination between patient and examiner).

To answer your request, I would need a document related to an AI/ML or diagnostic device that describes performance studies, acceptance criteria, and ground truth establishment.

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