(98 days)
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would allow me to answer your request. The document is an FDA 510(k) clearance letter for "Powder-Free Blue Nitrile Examination Gloves," which primarily confirms substantial equivalence to a predicate device and outlines regulatory compliance. It does not include a technical evaluation or performance data.
§ 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.