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This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
CAUTION: Safe use of this glove by on or latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions.

Non-Sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device that would involve AI, human readers, or specific performance metrics like sensitivity or specificity.

The document is a 510(k) clearance letter from the FDA for Non-sterile, Powder-Free Latex Examination Gloves. This type of device does not typically involve complex performance studies with AI, human interpretation, or ground truth establishment in the way described in your request. The clearance is based on substantial equivalence to legally marketed predicate devices, and the "Indications for Use" section simply describes the intended use of the gloves for preventing contamination.

Therefore, I cannot provide the requested information as it is not present in the given text.

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