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The Powder Free Polychloroprene Examination Glove Green, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Powder Free Polychloroprene Examination Glove Green, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This document is a marketing clearance letter from the FDA for a medical device: "Powder Free Polychloroprene Examination Glove Green". It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any AI-related studies.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls provisions. It specifies the regulation number (21 CFR 880.6250), regulation name (Patient Examination Glove), regulatory class (Class I), and product code (LZA). The "Indications for Use" section states that the glove is a disposable device made of synthetic rubber intended for medical purposes to prevent contamination between patient and examiner.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly for regulatory approval and does not delve into the performance evaluation metrics or study details typically associated with AI/medical device performance.

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