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A powder free Patient Examination Glove is a disposable device made of natural rubber latex or synthetic material intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. and as a barrier against potentially infectious materials and other contaminants.

A powder free Patient Examination Glove is a disposable device made of natural rubber latex or synthetic material intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. and as a barrier against potentially infectious materials and other contaminants.

This document is a 510(k) clearance letter from the FDA for a Powder Free Latex Patient Examination Glove.

Therefore, the input you provided does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML medical device. It's an approval letter for a physical medical product (gloves) and discusses regulatory compliance rather than performance studies with acceptance criteria as typically found for AI.

As such, I cannot extract the information required in your request (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, or ground truth establishment for training set) from this document. This document pertains to the regulatory clearance of a standard medical glove, not an AI/ML device.

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