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A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powdered Examination Glove

The provided document is a 510(k) premarket notification letter from the FDA for a Nitrile Blue Powdered Examination Glove. It is a regulatory document affirming equivalence to a predicate device and does not contain information about acceptance criteria or performance studies as typically described for a medical device that relies on algorithmic or diagnostic performance.

Therefore, I cannot answer your request regarding acceptance criteria and device performance studies because the information is not present in the provided text. The document is about a physical medical device (examination glove) that falls under general controls and does not involve AI or complex performance metrics as implied by your questions.

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