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

Powder-Free Synthetic Vinyl Examination Gloves, Yellow

This document is a 510(k) clearance letter from the FDA for Powder-Free Synthetic Vinyl Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot answer your request based on the provided text.

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

VINYL EXAMINATION GLOVE (Pre-POWDERED)

The provided text is a 510(k) premarket notification letter from the FDA regarding a "Powdered Vinyl Patient Examination Glove." This document is a regulatory approval letter and does not contain any information about acceptance criteria for a device, a study proving device performance, or any of the detailed aspects of a clinical study outlined in your request.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence and marketing approval, not on the technical performance specifications or clinical study results of the glove.

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Ask a specific question about this device