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

SMART-FEEL Powder Free Nitrile Examination Gloves (Pink Color)

The provided document is a 510(k) premarket notification letter for "Smart-Glove Powder Free Nitrile Examination Gloves Pink Color." This document is a regulatory approval letter from the FDA and does not contain information about acceptance criteria and a study proving device performance as described in the request.

Therefore, I cannot extract the requested information from this document. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

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

SMART-FEEL Powder Free Nitrile Examanation Gloves. (Natural, BLUE & Green)

The provided document is a 510(k) premarket notification letter from the FDA regarding "Smart-Feel Powder Free Nitrile Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. However, it does not involve the type of performance study typically conducted for AI/ML-driven medical devices that would have acceptance criteria and detailed study results. The information requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies) is not relevant or present in this specific type of regulatory document, as it pertains to a medical glove, not an AI software.

Therefore, I cannot provide the requested information based on the input document.

Ask a specific question about this device