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Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Disposable Medical Nitrile Examination Gloves

This document pertains to the 510(k) premarket notification for Disposable Medical Nitrile Examination Gloves. The information provided focuses on the regulatory clearance process for this medical device.

Crucially, this document does not describe an AI/ML-based medical device. Therefore, it does not contain the information needed to answer your specific questions regarding acceptance criteria, study methodologies (like MRMC, standalone performance), ground truth establishment, or sample sizes related to AI model evaluation.

The provided text from the FDA 510(k) clearance letter confirms that the device (disposable medical gloves) is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section simply describes the intended use of the gloves (to prevent contamination).

To answer your questions, the input document would need to be focused on the clinical validation or performance study of an AI/ML medical device.

Therefore, I cannot extract the requested information from the provided text because it describes a Class I medical device (gloves) and not an AI/ML medical device.

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