(107 days)
The Nitrile Powder Free Examination Gloves is a non - sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Not Found
This document is an FDA 510(k) clearance letter for various colors of Nitrile Powder Free Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria, as it is not a submission for an AI/ML or diagnostic device.
Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance of examination gloves, which are assessed based on physical properties and safety rather than performance metrics of an algorithm.
§ 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.