(363 days)
A patient examination glove is disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
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This document is an FDA 510(k) clearance letter for Nitrile Examination Powder Free Gloves. It does not contain information about an AI/ML medical device, its acceptance criteria, or a study proving that such a device meets acceptance criteria.
The information provided in the prompt, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set," "Number of experts used to establish the ground truth," and "If a multi reader multi case (MRMC) comparative effectiveness study was done," are all relevant to the evaluation of AI/ML-driven medical devices. However, this document is for a physical medical device (gloves) and therefore does not include any of these details.
To answer your request, I would need a document related to an AI/ML medical device, not a physical one.
§ 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.