(240 days)
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This looks like an FDA clearance letter for a medical device that does not use AI. There is no mention of acceptance criteria or a study related to AI performance. Therefore, I cannot provide the requested information about device performance against acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
The document discusses "Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color." This is a Class I medical device (non-powdered patient examination glove), which is a very low-risk device. Clearance for such devices typically involves demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical performance studies as would be required for higher-risk or AI-based devices.
The letter confirms that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements for the manufacturer.
§ 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.