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mCare® Powder Free Nitrile Black Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

mCare® Powder Free Nitrile Black Examination Glove

The provided text is a U.S. FDA 510(k) clearance letter for the mCare® Powder Free Nitrile Black Examination Glove. It is a regulatory document affirming substantial equivalence to a predicate device and discussing compliance requirements for marketing this Class I medical device. It is not a study report for a medical device that uses AI or complex algorithms, nor does it contain information about acceptance criteria or performance studies of such a device.

Therefore, I cannot provide the requested information because the document does not contain details about:

• Acceptance criteria table and reported device performance for an AI/algorithmic device.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for ground truth establishment.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set sample size or ground truth establishment for a training set.

The document discusses the regulatory classification of a glove and its intended use, which is a simple barrier device.

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