(305 days)
Biopro™, Nitrilon™, Correct Touch (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Biopro™, Nitrilon™, Correct Touch or any other private labeling Nitrile Powder Free Examination Gloves (Green, Purple)
I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a medical device. The document is an FDA 510(k) clearance letter for examination gloves, which primarily focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions "general controls" and "good manufacturing practice" but does not detail specific performance criteria or a study proving those criteria are met.
Therefore, I cannot provide the requested information based on the given input.
§ 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.