Search Results

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

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED.

This document is a 510(k) clearance letter from the FDA for medical gloves, not a study report. Therefore, it does not contain information on acceptance criteria or a study proving device performance as requested. The letter itself is part of the regulatory approval process which attests to the substantial equivalence of the device to a predicate device already on the market, but it doesn't detail the performance tests or data, nor does it discuss AI.

Therefore, I cannot provide the requested information based on the given input.

To fulfill your request, I would need a scientific study report or clinical trial results document that describes the device's performance, acceptance criteria, and the methodology of the study.

Ask a specific question about this device