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

Pre-powdered Nitrile Patient Examination Glove. BLUE AND WHITE (NON-GLORED)

The provided document is a 510(k) premarket notification letter from the FDA for a Powdered Nitrile Examination Glove. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The letter explicitly states it's a review of the company's "Section 510(k) notification of intent to market the device" and determines the device is "substantially equivalent" to legally marketed predicate devices. This indicates a traditional medical device (like gloves), not an AI/ML device that would require performance studies against specific acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.

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As a medical glove, wom on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Powdered Nitrile Examination Glove, Blue or White (non-colored)

I am sorry, but the provided text from the FDA 510(k) letter does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter is a notification of substantial equivalence for a Powdered Nitrile Examination Glove. It discusses the regulatory classification, general controls, and compliance with manufacturing practices, but it does not detail specific performance studies or acceptance criteria for the glove's functionality beyond its general indication for use as a medical glove. Therefore, I cannot generate the requested information based on this input.

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