(232 days)
Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors
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I am sorry, but the provided text from the FDA letter about Shen Wei USA Inc.'s Biodegradable Powder Free Nitrile Examination Glove does not contain information about acceptance criteria or a study proving device performance as it would relate to an AI/ML medical device.
The document is a 510(k) clearance letter for a Class I medical device (Non-Powdered Patient Examination Glove). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements for the manufacturer.
To fulfill your request, I would need a document related to an AI/ML medical device submission, which would detail performance studies and acceptance criteria.
§ 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.