(45 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a letter from the FDA regarding a 510(k) premarket notification for "Disposable Powder Free Vinyl Examination Gloves, with Vitamin E." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory responsibilities.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given 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.