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

PRE-POWDERED VINYL EXAM GLOVES

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria for an AI/ML-based medical device. Therefore, I cannot extract the requested information.

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

Powder-Free Vinyl Examination Gloves

I apologize, but the provided text does not contain information about the acceptance criteria or a study proving a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Powder-Free Vinyl Examination Gloves" (K042952), confirming their substantial equivalence to legally marketed predicate devices.

It discusses regulatory aspects, compliance requirements, and indications for use of the gloves, but it does not detail performance acceptance criteria or any study results to demonstrate those criteria were met.

Therefore, I cannot provide the requested information.

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