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

Powder Free Yellow Synthetic Vinyl Patient Examination Gloves

The provided text is a letter from the FDA regarding the 510(k) premarket notification for "Powder Free Yellow Synthetic Vinyl Patient Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself or in detailed study reports, not in the FDA's regulatory clearance letter.

Therefore, I cannot provide the requested information based on the input text.

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