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

Syntex Pre-Powdered Latex Examination Glove

The provided text is a FDA 510(k) clearance letter for a medical device: "Syntex Pre-Powdered Latex Examination Glove."

This type of document does not contain the detailed technical information requested about acceptance criteria and study designs that prove device performance.

FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new, extensive clinical studies proving efficacy or specific performance metrics in the way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information from the given input. The letter essentially states that the device is "substantially equivalent" for its indicated use based on the information provided in the 510(k) submission, and it lists various regulatory requirements for the manufacturer.

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