(28 days)
A nowder liee patient examination glove is a disposable device made of synthetic material that may bear a tracc annount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
POWDER FREE NITRILE EXAMINATION GLOVES
The provided document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves" (K993258). It does not contain sections detailing acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device.
This document is from 1999 and pertains to a physical medical device (gloves), not an AI/ML powered device. Therefore, the requested information categories are not applicable to the content of this document.
§ 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.