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The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color

This document is a 510(k) clearance letter from the FDA for a Disposable Powder Free Nitrile Examination Glove. It does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.

The provided text pertains to a Class I medical device (patient examination glove), which typically only requires demonstration of substantial equivalence to a predicate device, not clinical performance studies with acceptance criteria as would be expected for AI/ML devices.

Therefore, I cannot provide the requested information based on the input text. The questions relating to sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details are not applicable to the clearance of a medical glove.

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