(88 days)
The Medline Glide-On 3G Vinyl Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Not Found
This document is an FDA 510(k) clearance letter for a medical device: "Medline Glide-On 3G Vinyl Examination Gloves". This type of document declares substantial equivalence to a predicate device and does not contain information about the acceptance criteria and study detailed in the request. The request asks for details related to an AI/ML medical device, which is not what this document describes. 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.