(20 days)
A 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.
Powdered Blue Nitrile Examination Gloves
The provided text is a 510(k) clearance letter from the FDA for "Powdered Blue Nitrile Examination Gloves." This document does not contain any information about the acceptance criteria or study results for a device that relies on algorithms or AI.
The letter pertains to a physical medical device (examination gloves) and focuses on its substantial equivalence to a predicate device, as required for 510(k) clearance. Therefore, it does not include the type of information requested about artificial intelligence performance metrics, training sets, expert ground truth, or MRMC studies.
To answer your request, I would need a document that describes the evaluation of an AI-powered medical device.
§ 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.