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The provided text is a 510(k) clearance letter from the FDA for "Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors."
This document does not contain any information about an AI/ML medical device, its acceptance criteria, or a study proving its performance. It specifically relates to a Class I medical device (non-powdered patient examination glove) and focuses on regulatory aspects like substantial equivalence, general controls, and compliance.
Therefore, I cannot provide the requested information about acceptance criteria and a study to prove a device meets them, as the provided input does not describe such a device or 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.