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Non Sterile Powder Free Polyurethane Examination Glove (Blue and Black colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)

This document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria, device performance metrics, or study details (sample size, data provenance, ground truth establishment, MRMC studies, standalone performance, etc.) for a medical device that would typically involve such a study (e.g., an AI-powered diagnostic device or a complex therapeutic device).

The information provided is purely administrative for a Class I medical device (non-powdered patient examination glove), indicating FDA clearance based on substantial equivalence rather than a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested table and study details based on the provided text.

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