(36 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Grape Scented, Blue and White color
The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves, Grape Scented, Blue And White Color". It primarily focuses on the regulatory approval and substantial equivalence determination for this medical device.
This document does NOT contain information about acceptance criteria, device performance studies, ground truth establishment, sample sizes for training or testing, or expert qualifications for AI/ML device evaluation.
Therefore, I cannot provide the requested information from the given text. The request is based on the assumption that the document describes an AI/ML medical device, which is not the case here. This document pertains to a physical medical device (gloves) and its regulatory clearance process, not a software algorithm that would have the study components listed in your request.
§ 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.