(64 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Sterile, Powder Free Nitrile Examination Gloves, Blue
I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Sterile, Powder Free Nitrile Examination Gloves, Blue." It does not contain information about acceptance criteria or a study that proves a device meets such criteria. Therefore, I cannot fulfill your request for that specific information based on the input given.
§ 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.