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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE

This document is a 510(k) premarket notification letter from the FDA regarding "Disposable PVC Synthetic Examination Gloves, Powder Free." It states that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It is a regulatory clearance document, not a performance study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. This type of information is typically found in the 510(k) submission itself, which is a much more extensive document than this clearance letter.

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