(184 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Patient Examination Glove, Powdered
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Vinyl Patient Examination Glove, Powdered." It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study for the device based on the given input.
§ 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.