(104 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. This device also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy (Blue)
This document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy (Blue)". It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device.
Therefore, I cannot answer the question based on the provided text. The document is about medical gloves, not an AI/ML device, and thus doesn't discuss performance metrics like sensitivity, specificity, or typical study designs for AI systems.
§ 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.