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A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.

A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.

This document is a 510(k) premarket notification decision letter from the FDA for surgical gloves. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The letter pertains to the "Eclipse Latex Powder Free Sterile Surgeon's Glove" and primarily confirms its substantial equivalence to previously marketed predicate devices under the 510(k) process. This is a regulatory pathway for medical devices that are similar to existing ones and does not typically involve detailed performance studies with acceptance criteria as would be expected for a novel AI/ML device.

Therefore, I cannot provide the requested information from the given text.

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