(243 days)
A Synthetic Vinyl Examination Glove Powder Free coated with Allogel(Green/Blue/White/Magenta/Clear (non colored)) 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.
Synthetic Vinyl Examination Glove Powder Free Coated With Allogel (Green/Blue/White/Magenta/Clear (non colored))
I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for a medical device (Synthetic Vinyl Examination Glove), and it primarily addresses the substantial equivalence determination. It does not include details about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies as would be expected for an AI/CAD diagnostic 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.