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

BLUE NITRILE EXAMINATION GLOVES, POWDER FREE.

The provided document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to AI/ML or a more complex medical device. Instead, it confirms that the Nitrile Examination Gloves Powder Free (Blue Color) are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given text. The document is primarily an administrative letter about regulatory approval for a low-risk medical device (patient examination gloves).

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