(64 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or and finger to prevent contamination between patient examiner.
Powderfree Patient Nitrile Examination Glove ( Blue Colour )
This document is a 510(k) clearance letter from the FDA for Powderfree Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The letter is a regulatory approval for a physical medical product (gloves) based on substantial equivalence to previously marketed devices, not an evaluation of a data-driven device.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from 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.