(135 days)
A patient examination glove is a disposable device intended for medical purpose that A patient examiner's hands or finger to prevent contamination between patient and examiner.
PRE-POWDERED VINYL EXAM GLOVES
This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria for an AI/ML-based medical device. Therefore, I cannot extract the requested information.
§ 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.