(47 days)
A powdered vinyl examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Not Found
This document is a 510(k) summary for powdered vinyl examination gloves. It does not contain information about the acceptance criteria or a study proving device performance as typically understood for AI/ML devices. The document is an FDA letter granting substantial equivalence for a medical device which is a physical product (gloves), not an AI/ML software.
Therefore, I cannot provide 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.