(41 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDERED VINYL EXAM GLOVES
The provided text is a 510(k) premarket notification approval letter for "Disposable Powdered Vinyl Examination Gloves". This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device. Therefore, I cannot generate the requested table and study details.
The document is a regulatory approval for a medical device and focuses on its substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics and studies that would be associated with an AI/ML product.
§ 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.