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POWDERED NITRILE BLUE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.

POWDERED NITRILE BLUE EXAMINATION GLOVES

The provided document is an FDA 510(k) clearance letter for Powdered Nitrile Blue Examination Gloves. It primarily addresses the regulatory approval of the device and its indications for use. The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific ground truth methodologies for evaluating the gloves.

Therefore, I cannot fulfill the request for information on acceptance criteria and supporting studies based on the provided text. The document confirms that the device is "substantially equivalent" to previously marketed devices, which speaks to its regulatory classification rather than detailed performance metrics from a specific study against defined acceptance criteria.

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