(38 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 Patient Examination Gloves- Pre-powdered
I am sorry, but the provided text is a letter from the FDA regarding the clearance of Vinyl Patient Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance for the product. Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study as the necessary information is not present in the given document.
§ 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.