(45 days)
The nitrile examination glove is a disposable device intended and dental purposes that The mirrite examiner's hand to prevent contamination between the patient and examiner.
FreeForm Blue Powder Free Nitrile Examination Gloves (Cornflower Blue)
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "FreeForm Blue Powder Free Nitrile Examination Glove". It does not contain information about the acceptance criteria, study details, or performance of a device in the context of AI/ML or medical imaging studies as outlined in your request.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.
§ 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.