(53 days)
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Nitrile Examination Gloves, Powder Free, Blue Glove
This document is a marketing clearance letter from the FDA for Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as described in the prompt. The letter confirms substantial equivalence to a predicate device and allows the manufacturer to market the gloves, subject to general controls.
Therefore, I cannot provide the requested information from the provided 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.