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As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Powder-Free, Poly-Coated Nitrile Examination Glove, Purple or White (noncolored)

This document is a 510(k) clearance letter from the FDA for a medical device: "Powder-Free Nitrile, Poly-Coated Examination Glove, Purple or White (Non-colored)".

The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document.

This letter is a regulatory approval notice, indicating that the device has been found substantially equivalent to a pre-existing legally marketed device. It does not contain the detailed technical performance study results, acceptance criteria, or specific ground truth methodologies that would typically be found in a 510(k) submission's performance data section.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided text.

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