(109 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 nations and examiner.
VINYL EXAMINATION GLOVE (Pre-POWDERED)
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Powdered Vinyl Patient Examination Glove." This document is a regulatory approval letter and does not contain any information about acceptance criteria for a device, a study proving device performance, or any of the detailed aspects of a clinical study outlined in your request.
Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence and marketing approval, not on the technical performance specifications or clinical study results of the glove.
§ 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.