(231 days)
The powder Free Nitrile Examination Gloves(Cobalt Blue,Black,Blue) 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.
The powder Free Nitrile Examination Gloves(Cobalt Blue,Black,Blue and Violet Blue)
I am sorry, but the provided text from the FDA letter (K182612 for Powder Free Nitrile Examination Gloves) does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the detailed data typically associated with the efficacy or performance validation of an AI/ML-based medical device.
The document is a 510(k) clearance letter for examination gloves, which are Class I medical devices subject to general controls and substantial equivalence determination. The review process for such devices focuses on manufacturing, labeling, and substantial equivalence to a legally marketed predicate device, rather than detailed performance studies like those required for advanced diagnostic or therapeutic devices that utilize AI/ML.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details 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.