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

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This document does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria.

The provided text is an FDA 510(k) clearance letter for a "Latex Examination Powder Free Glove, Aloe Vera" (K193150). It states that the device is substantially equivalent to legally marketed predicate devices.

This type of FDA clearance relies on demonstrating substantial equivalence to a predicate device, rather than performing specific clinical studies to meet pre-defined performance acceptance criteria as would typically be required for a novel device or AI-powered medical device.

Therefore, I cannot provide the requested information, which would typically be found in a performance study report or a different section of a submission for a device that requires such evaluation.

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