(106 days)
The Powder Free Nitrile Examination Gloves (Blue, White, Blue, Cobalt blue) 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.
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt Blue)
Please provide the text that describes the acceptance criteria and the study that proves the device meets the acceptance criteria. The document you provided is an FDA 510(k) clearance letter for examination gloves, which details regulatory information and indications for use, but does not contain a study plan or results demonstrating performance against specific acceptance criteria for a medical device's functionality (e.g., an AI/ML diagnostic tool).
Therefore, based on the provided text, I cannot extract the information required to answer your questions about acceptance criteria and study results.
If you can provide a document that contains information about a performance study for a medical device (especially one involving AI or a diagnostic tool), I would be happy to help you extract the requested 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.