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A medical glove is worn on the hand of healthcare and similar personnel to prevent / moundal you between health care personnel and the patient.

Omni Flex Nitrile Examination Glove, Powder Free, Blue

This document is a 510(k) premarket notification letter from the FDA to OmniGrace (Thailand) Ltd. regarding their Omni Flex Nitrile Examination Glove. It is primarily a regulatory approval document and does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about specific studies (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set size, or how ground truth was established).

The "Indications For Use Statement" only describes the intended purpose of the glove (to prevent contamination between healthcare personnel and the patient) but does not include any performance metrics or study details.

Therefore, I cannot provide the requested information from this document.

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