(21 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Powder-Free Polychloroprene Patient Examination Glove
This is a 510(k) premarket notification for "Powder-Free Polychloroprene Patient Examination Gloves" and does not contain information about software with acceptance criteria or a study demonstrating device performance.
The provided text is a letter from the FDA confirming substantial equivalence of the gloves to a legally marketed predicate device. It discusses regulatory matters such as registration, listing, good manufacturing practice, and labeling, but does not describe any technical performance criteria or a study with results.
Therefore, I cannot provide the requested information.
§ 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.