(93 days)
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
POWDER FREE BLUE NITRILE GLOVE
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Blue Nitrile Examination Glove". It primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for an AI/ML medical device.
The information requested in the prompt (acceptance criteria, study details, expert involvement, etc.) is typically found in the technical documentation of a medical device submission, particularly for AI/ML devices, and is not part of this FDA clearance letter.
Therefore, I cannot extract the requested information from the provided text.
§ 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.