(69 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 Powder Free Examination Gloves Non-Sterile
This document is a 510(k) premarket notification from the FDA for NBR 4 Mils Nitrile Powder-Free Examination Gloves. It details the FDA's decision regarding the substantial equivalence of the device.
However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter acknowledges the submission and clarifies regulatory aspects but does not include technical performance data, test results, or study details.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, rather than detailed performance and study data.
§ 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.