(35 days)
The Synthalon® PI Powder-free Synthetic Polyisoprene/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® PI Powder-free Synthetic Polyisoprene/Polychloroprene Examination Glove
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document appears to be an FDA 510(k) clearance letter for a medical glove, focusing on regulatory aspects, indications for use, and substantial equivalence to a predicate device. It does not include details on performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
§ 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.