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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 Latex Examination Gloves

This document is a 510(k) clearance letter from the FDA for Powder-Free Latex Examination Gloves. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on demonstrating equivalence through comparison to an existing device, rather than requiring new clinical studies to establish performance against defined acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. The document indicates that the device is "substantially equivalent" to devices marketed prior to May 28, 1976, and outlines general regulatory compliance rather than specific performance metrics or studies.

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