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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250) .

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

This document is a 510(k) clearance letter from the FDA for "Patient Vinyl Examination Gloves, PowderFree, Non-Sterile." It grants market clearance based on substantial equivalence to existing devices. As such, it does not contain the detailed study information regarding acceptance criteria and performance of a new medical device that you're looking for.

Instead, this letter confirms that the device is a Class I medical device and is subject to general controls. For these types of devices, performance testing often focuses on established standards (e.g., ASTM standards for gloves) and equivalence rather than complex clinical studies with ground truth establishment and MRMC analysis.

Therefore, I cannot extract the information you requested from this document. The document primarily focuses on regulatory clearance, not detailed device performance study results.

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