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

Non-sterile, powder-free latex examination gloves with polymer coating, vitamin E, and protein claim (50 micrograms or less).

The provided document is a 510(k) summary for non-sterile, powder-free latex examination gloves. It does not describe an AI/ML powered medical device, nor does it contain information about a study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods for an AI/ML device.

Instead, this document is concerned with demonstrating substantial equivalence to a predicate device (Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794) for regulatory purposes. The comparison table confirms that the new device has "Identical" or "Similar" characteristics to the predicate device across various technological aspects.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as this document is not about such a device.

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