(101 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Non Colored
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It primarily discusses regulatory compliance and the substantial equivalence determination for the device.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study to prove the device meets those criteria based on the given 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.