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A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.

Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves.

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves." This document is a regulatory approval letter and does not contain any information about the acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or performance metrics typical of studies proving device effectiveness.

The document primarily states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. It covers administrative aspects such as classification, general controls, and compliance with regulations.

Therefore, I cannot provide the requested information based on the content of this document.

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