(17 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 patient and examiner.
Powder Free Sterile Synthetic Vinyl Examination Gloves
I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Synthetic Vinyl Patient Examination Gloves" and pertains to regulatory approval, not device performance studies or acceptance criteria. Therefore, I cannot extract the table of acceptance criteria, device performance, or details about any study as this information is not present in 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.