(56 days)
A pation cxamination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Latex Patient Examination Gloves (Powder-Trade Name: Free) with Protein Content Labeling Claim (50 micrograms or less)
Please provide the "Input" in the format specified by your request. The current input is malformed, with page numbers and descriptive text mixed with the content. I need a clear, contiguous block of text for analysis.
Once formatted correctly, I will be able to extract the requested information about acceptance criteria and the study proving device conformance.
§ 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.