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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

POWDERED NITRILE EXAMINATION GLOVE

I am sorry, but the provided document is a 510(k) clearance letter from the FDA for a Nitrile Examination Glove, not a medical device that uses AI or requires a study with acceptance criteria and performance metrics in the way you've described.

The document discusses:

• The FDA's review of a 510(k) notification.
• The determination of substantial equivalence to a legally marketed predicate device.
• Regulatory classifications and general controls provisions of the Act.
• Indications for use for the glove: "This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."

Therefore, I cannot provide the information you requested about acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics because it is not relevant to the subject matter of this document.

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