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

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This document is a 510(k) summary for powdered vinyl examination gloves. It does not contain information about the acceptance criteria or a study proving device performance as typically understood for AI/ML devices. The document is an FDA letter granting substantial equivalence for a medical device which is a physical product (gloves), not an AI/ML software.

Therefore, I cannot provide the requested information.

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