(46 days)
Brightway™ Brand Nitrile Examination Glove (Powder Free) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Brightway™ Brand Nitrile Examination Gloves (Powder Free)
Please note that the provided document is a 510(k) clearance letter from the FDA for medical gloves, not a study report for an AI device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving device performance for an AI system.
The document discusses the classification of "Brightway™ Brand Nitrile Examination Glove (Powder-Free)" as a Class I regulatory device and its substantial equivalence to previously marketed devices. It outlines general controls provisions for such devices, including good manufacturing practices, labeling, and prohibitions against misbranding.
Therefore, I cannot extract the information required in your request 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.