(257 days)
A powder-free nitrile examination gloves is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent cross-contamination between patient and examiner.
Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
This document is a 510(k) clearance letter from the FDA for "Disposable Nitrile Powder Free Examination Gloves (Non-sterile)." It is not a study describing acceptance criteria or performance data for an AI/ML medical device.
Therefore, I cannot provide the requested information about acceptance criteria and study details as it pertains to AI/ML devices. The document concerns traditional medical devices (examination gloves) and focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than performance data against specific acceptance criteria for an AI algorithm.
§ 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.