(47 days)
The Synthalon® PC Plus Powder-free Polychloroprene 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.
Synthalon® PC Plus Powder-free Polychloroprene Examination Glove
This document is a 510(k) premarket notification letter from the FDA regarding a medical glove. It does not contain information about acceptance criteria or a study proving device performance in the way typically expected for an AI/ML medical device.
Therefore, I cannot provide the requested table and study details. The document is a regulatory approval for a physical medical device (examination glove) based on substantial equivalence to a predicate device, not on clinical performance metrics or AI algorithm evaluation.
§ 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.