(92 days)
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.