(45 days)
This device is 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 is a 510(k) clearance letter from the FDA for "Disposable Medical Nitrile Examination Gloves." It does not contain information about acceptance criteria or a study proving that an AI-powered device meets acceptance criteria. The document is strictly for a medical glove, which is a physical medical device, not a software or AI-driven diagnostic tool. Therefore, I cannot extract the requested information from this document.
§ 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.