(58 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
This document is a 510(k) clearance letter from the FDA for "Disposable Vinyl Synthetic Medical Gloves, Powder-Free" (K982704). It confirms the device is substantially equivalent to legally marketed predicate devices.
The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. These types of details are not typically included in an FDA clearance letter, which primarily focuses on regulatory approval and substantial equivalence.
Therefore, I cannot provide the requested information from the given 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.