(133 days)
The Nitrile Powder Free Examination Glove is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Powder Free Examination Glove (Aqua Blue); Nitrile Powder Free Examination Glove (Aqua Blue)-Extended Cuff; Nitrile Powder Free Examination Glove (Orange); Nitrile Powder Free Examination Glove (Orange)-Extended Cuff; Nitrile Powder Free Examination Glove (Black); Nitrile Powder Free Examination Glove (Black)- Extended Cuff
This document is a 510(k) premarket notification decision letter from the FDA regarding several types of Nitrile Powder Free Examination Gloves. It primarily confirms substantial equivalence to predicate devices and outlines regulatory compliance. It does not contain any information about a study proving device performance against acceptance criteria using retrospective or prospective data, expert ground truth, or an AI algorithm.
Therefore, I cannot provide the requested details about acceptance criteria or a study based on the provided text. The document focuses on regulatory approval based on equivalence, not on the performance of a device as evaluated in a clinical or analytical study.
§ 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.