(33 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.
Powdered Synthetic Vinyl Examination Glove
This document only discusses the FDA's decision to allow the marketing of "Powdered Synthetic Vinyl Examination Gloves" and does not contain information about acceptance criteria or a study proving the device meets those criteria. It is a 510(k) premarket notification letter, which indicates substantial equivalence to a predicate device, rather than a clinical study report. Therefore, I cannot extract the requested information.
§ 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.