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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 examiners.

Powder-Free Nitrile Examination Glove

The provided text is a 510(k) clearance letter from the FDA for "Health-Plus, Sanitex, Reliance Powder-Free Trade Name: Nitrile Examination Gloves." This document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria. The letter is a regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given input. The document is about regulatory approval, not performance study details.

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