(49 days)
As a medical glove, wom on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Powdered Nitrile Examination Glove, Blue or White (non-colored)
I am sorry, but the provided text from the FDA 510(k) letter does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter is a notification of substantial equivalence for a Powdered Nitrile Examination Glove. It discusses the regulatory classification, general controls, and compliance with manufacturing practices, but it does not detail specific performance studies or acceptance criteria for the glove's functionality beyond its general indication for use as a medical glove. Therefore, I cannot generate the requested information based on this input.
§ 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.