(61 days)
A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Blue Powder Free Examination Glove
The provided document is a 510(k) clearance letter from the FDA for a Nitrile Blue Powder Free Examination Glove. This document does not contain information about acceptance criteria or a study proving that an AI device meets these criteria. The approval is for a physical medical device (examination glove), not an AI-powered diagnostic or therapeutic tool.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, expert qualifications, or AI-related metrics like MRMC studies or standalone AI performance.
§ 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.