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A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

SUPERGLOVES Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.

The document is an FDA 510(k) clearance letter for "SUPERGLOVES® Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)". It confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The letter mentions general controls provisions and regulatory requirements but does not include any performance study data or detailed acceptance criteria.

The "Indications for Use" section defines what the gloves are for, but it does not contain any performance metrics or criteria.

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