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A medical gloves i ; worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

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This document is a 510(k) clearance letter from the FDA for "Brothers Vinyl, Powder-Free, Patient Examination Gloves." It does not contain any information about acceptance criteria or a study proving device performance, as is typical for most 510(k) clearances, especially for Class I devices like examination gloves.

The letter explicitly states: "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the device was cleared because it was shown to be as safe and effective as a legally marketed predicate device, not because a new study was conducted to establish specific performance criteria or benchmarks.

Therefore, I cannot extract the requested information from this document. It is a regulatory clearance, not a technical report detailing performance studies.

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