(78 days)
A Stretch Vinyl examination glove(Yellow/white) 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.
Powder-Free, Stretch Vinyl Examination Gloves, Yellow/White
The provided text is a 510(k) premarket notification letter from the FDA to Novapro Company, Limited regarding their Powder-Free, Stretch Vinyl Examination Gloves, Yellow/White. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/device study.
The letter is an approval for a medical device (examination gloves) based on a determination of substantial equivalence to legally marketed predicate devices, not on the results of a specific performance study in the way one would describe for an AI/diagnostic device.
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided input.
§ 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.