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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.

UNISEAL Powder Free Latex Examination Gloves (BLUE + GREEN)

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for examination gloves. It does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device. Therefore, I cannot fulfill your request based on the given context.

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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.

Uniseal Powdered Latex Examination Glove with Protein Content Labeling Claim (100 micrograms or less)

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device (Uniseal Latex Examination Gloves) and primarily discusses the regulatory approval process. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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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.

UNISEAL POWDER-FREE NITRILE EXAMINATION GLOVES

I'm sorry, but this document contains a letter from the FDA regarding the substantial equivalence of Uniseal Nitrile Powder-Free Examination Gloves to a predicate device. It does not contain information about acceptance criteria and a study proving a device meets those criteria, as requested in your prompt. The document is a regulatory notification, not a performance study report.

Therefore, I cannot extract the requested information from this document.

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