(51 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.
Powder Free Nitrile Examination Gloves, Orange
This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Examination Gloves, Orange." It establishes substantial equivalence for a medical device but does not contain information about acceptance criteria or a study proving device performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
§ 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.