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A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

LOPRP, AVT, EXAM-PERFECT, GUARDIAN, MILLENIUM FUS S2 & HEALTH TEC - Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less)

The provided text is a set of FDA letters concerning a 510(k) premarket notification for latex examination gloves. It does not describe any acceptance criteria, device performance, or study details (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size or ground truth establishment) as requested in the prompt.

Therefore, I cannot provide the requested information from the given text.

The text primarily focuses on:

• Confirmation of the device being substantially equivalent to legally marketed predicate devices.
• Instructions regarding general controls provisions, potential additional controls, and compliance with regulations.
• The indications for use of the gloves ("A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.").
• Product names (LOPRO, AVT Exam-Perfect, Guardian, Millenium Fusion S2 & Health Tec Powder-Free Latex Examination Glove) and classification as over-the-counter.

No performance data or study methodology is present in these documents.

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