(40 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.
Powder-Free Nitrile Patient Examination Gove, White (non-colored) and Blue Colored
I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Nitrile Patient Examination Glove." It discusses the regulatory classification and marketing authorization of the device.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These types of details are typically found in the 510(k) summary or detailed reports, which are not included in 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.