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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.

Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or less)

This is a 510(k) premarket notification for "Superqloves Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less)". This document is an FDA clearance letter and not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. The "Indications For Use" section describes the intended purpose of the gloves, but not specific performance metrics or the studies used to demonstrate them.

To answer your questions, if such a study was performed, it would be found in the manufacturer's submission to the FDA, which is not publicly available in this document.

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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.

SUPERGLOVES Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set details.

The document is an FDA 510(k) clearance letter for "SUPERGLOVES® Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)". It confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. The letter mentions general controls provisions and regulatory requirements but does not include any performance study data or detailed acceptance criteria.

The "Indications for Use" section defines what the gloves are for, but it does not contain any performance metrics or criteria.

Ask a specific question about this device