(243 days)
Powder-Free White Vinyl Patient Examination Gloves 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 White Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
I am sorry, but the provided text describes a 510(k) premarket notification for "Powder-Free White Vinyl Patient Examination Gloves," seeking substantial equivalence to a predicate device.
The document does not contain information about a medical device that utilizes AI, machine learning, or complex algorithms requiring extensive testing with test sets, expert ground truth, or multi-reader multi-case studies. It focuses on the physical and performance characteristics of medical gloves, adhering to established ASTM standards and FDA regulations for such devices.
Therefore, I cannot extract the information required to populate the tables and answer the questions related to acceptance criteria, AI performance studies, expert adjudication, or training data for a complex algorithmic device.
§ 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.