(72 days)
A medical glove is worn on the hand of the health care and similar personnel to Prevent contamination between the personnel and the patient being treated.
NBR 4 Mils, Nitrile Examination Glove Non-Sterile, powdered
This is a letter from the FDA regarding a 510(k) submission for a medical device (nitrile examination glove). It primarily discusses the device's substantial equivalence to a predicate device and its regulatory classification, allowing it to be marketed. The document does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations. It's a regulatory approval letter, not a clinical study report.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.