(56 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 VINYL EXAMINATION GLOVES, YELLOW COLOR POWDER FREE WITH VITAMIN E
This document is a 510(k) clearance letter from the FDA for disposable vinyl examination gloves. It does not contain information on acceptance criteria or a study proving the device meets those criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. 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.