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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-Free Nitrile Examination Glove -- Purple Color

The provided document is a 510(k) clearance letter from the FDA for a device called "Syntex Powder-Free Nitrile Examination Glove, Purple Color." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI or comparative effectiveness studies.

The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a device already on the market, based on its indications for use, technological characteristics, and performance data. However, the performance data itself, including specific acceptance criteria and study results, is typically found in the 510(k) submission summary, which is not part of this letter.

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

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