(38 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
I'm sorry, but your query cannot be fulfilled. The document provided is an FDA 510(k) clearance letter for a medical device (Disposable Powder Free Vinyl Synthetic Exam Gloves). It confirms that the device has been found substantially equivalent to a legally marketed predicate device.
The document does not contain any information about the acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement that would be necessary to answer your specific questions. These details are typically found in the actual 510(k) submission, not in the clearance letter itself.
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.