(139 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Examination Gloves, Powder Free, with Vitamin E
This document is an FDA 510(k) clearance letter for "Vinyl Examination Gloves, Powder Free with Vitamin E". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
Therefore, this document does not contain information related to software or AI-powered medical devices. As such, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or sample sizes related to AI device performance.
The provided text focuses on regulatory approval for examination gloves based on substantial equivalence, not on performance metrics of a diagnostic or therapeutic AI/software 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.