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

Powdered Yellow Synthetic Vinyl Patient Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Powdered Yellow Synthetic Vinyl Patient Examination Gloves." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Instead, the document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but those characteristics do not raise new questions of safety and effectiveness and are shown to be at least as safe and effective as the predicate device.

Therefore, I cannot answer the request as the necessary information for acceptance criteria and a study proving the device meets them is not present in the provided text.

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