(55 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
VFlex, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray Color
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "VFlex, Powder Free Nitrile Examination Gloves." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines general regulatory requirements.
However, the document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.
§ 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.