(158 days)
A 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.
Not Found
The provided document is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/software as a medical device (SaMD).
The document is for "Powder Free Pink Polychloroprene Copolymer Examination Gloves" and "Powder Free Black Polychloroprene Copolymer Examination Gloves," which are Class I medical devices (physical products, not software). The FDA's review for these physical devices focuses on substantial equivalence to predicate devices based on indications for use, without requiring clinical performance studies like those for AI/SaMD.
Therefore, I cannot provide the requested information from the given text as it pertains to AI/SaMD.
§ 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.