(137 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Examination Gloves, Pre-Powdered, with Vitamin E
The provided text is a U.S. FDA 510(k) clearance letter for "Vinyl Examination Gloves, Pre-Powdered with Vitamin E." This document is a regulatory approval and does not contain information on acceptance criteria or a study proving the device meets those criteria, as requested in the prompt.
The 510(k) process primarily evaluates substantial equivalence to a legally marketed predicate device, rather than detailed performance study results against specific criteria in the way a clinical trial or a performance study for a diagnostic AI device would.
Therefore, I cannot provide the requested information 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.