(52 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 Latex Patient Examination Glove, White (non-colored) or Blue Colored, with extractable protein content labelling claim (50 microgram per gram of glove or less)
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the "Powder-Free Latex Patient Examination Glove."
The document is a 510(k) premarket notification letter from the FDA, indicating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, labeling requirements, and contact information but does not contain data from performance studies.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth, or expert qualifications.
§ 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.