(30 days)
Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Green Nitrile Examination Gloves
This document is a letter from the FDA regarding a 510(k) premarket notification for "Powderfree Green Nitrile Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies of an AI device.
Therefore, I cannot fulfill the request as the provided text pertains to regulatory approval for medical gloves and not to the evaluation of a medical device using the specified metrics.
§ 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.