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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." [50 Microgram or less Protein labeling Claim]

Polymer Coated Powder Free Latex Examination Gloves

This document is a 510(k) premarket notification letter from the FDA regarding "Latex Examination Gloves (50 mcg or less protein labeling claim)". It concerns the regulatory approval of a medical device, which is a type of glove, and does not involve AI or an algorithm. Therefore, none of the requested information about AI device acceptance criteria, study data, ground truth, or MRMC studies is applicable to this document.

The document primarily states that the device is substantially equivalent to legally marketed devices and can be marketed subject to general controls. It details the product name, applicant, 510(k) number, and indications for use, which are as follows:

Indications For Use: "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." with a "[50 Microgram or less Protein labeling Claim]".

The document does not contain information on device performance metrics, study designs, sample sizes, or expert qualifications as it is a regulatory approval letter based on substantial equivalence, not a performance study report for an AI device.

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