(42 days)
A 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.
Synthetic Powder Free Vinyl Patient Exam Gloves
This document is a 510(k) premarket notification for a medical device: "Powdered Free Synthetic Vinyl Examination Glove," regulated under 21 CFR 880.6250 (Patient Examination Gloves). The FDA letter indicates that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory clearance letter, not a technical study report.
Therefore, I cannot fulfill your request for the detailed information outlined in points 1 through 9. The document only confirms the device's regulatory classification and that it can be marketed.
§ 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.