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

Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Protein Content labeling Claim (50 micrograms or less)

This document is a 510(k) premarket notification approval letter from the FDA for medical gloves. It does not describe an AI/ML device or its performance criteria, study design, or results. Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document discusses the approval of "Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 Micrograms or Less)." The letter confirms that this device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.

The "Indications For Use" section states: "A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient."

No information regarding AI/ML device performance, acceptance criteria, or study details can be extracted from this document.

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