(147 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Blue Nitrile Examination Gloves
The provided text is a letter from the FDA regarding the clearance of "Powder Free Nitrile Examination Gloves." It does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria. The letter primarily addresses the substantial equivalence determination for regulatory purposes. Therefore, I cannot extract the requested information from 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.