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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Pink

This document is a 510(k) clearance letter from the FDA for Powder Free Nitrile Examination Gloves. It primarily addresses regulatory approval and does not contain the detailed technical study information required to answer your specific questions about acceptance criteria and device performance evaluation as typically found in a clinical or performance study report for diagnostic or AI-enabled devices.

Therefore, I cannot provide the information requested in your prompt based on the provided text. The document focuses on the administrative process of market clearance for a class I medical device (gloves), which has a much lower regulatory bar and different submission requirements compared to a device that would require the kind of performance study details you are asking for.

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