(82 days)
Synthetic Vinyl examination glove, Powder Free 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.
Powder-Free, Synthetic Vinyl Examination Gloves
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free, Synthetic Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/software as a medical device (SaMD).
Instead, it's a regulatory approval document for a Class I medical device (patient examination glove). The "acceptance criteria" discussed in this document refer to regulatory compliance and the demonstration of substantial equivalence to an already legally marketed predicate device, rather than performance metrics from a technical study for a diagnostic or therapeutic device.
Therefore, I cannot extract the requested information (1-9) as it pertains to AI/SaMD performance studies 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.