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Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Disposable Medical Nitrile Examination Gloves (Non Sterile)

This document is an FDA 510(k) clearance letter for "Disposable Medical Nitrile Examination Gloves - Non Sterile." It does not contain any information about acceptance criteria or a study proving that a device meets those criteria, as it is not for a medical device that requires such evaluation (e.g., an AI/ML-based device, an imaging system, or a diagnostic test).

The document is a clearance for a Class I medical device (non-powdered patient examination glove) which falls under general controls and does not typically require extensive performance studies or clinical trials for market clearance. The "study" in this context refers to the substantial equivalence determination made by the FDA based on the provided information, not a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, or MRMC studies, as none of this information is present in the provided FDA clearance letter for examination gloves.

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