(81 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Patient Nitrile Examination Glove (Prepowdered)
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Patient Nitrile Examination Glove". This document does not contain information about acceptance criteria or a study proving that a device meets such criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information from the provided text. The questions you've asked are typically found in a clinical study report, acceptance testing protocol, or a scientific publication detailing device performance, which this document is not.
§ 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.