(87 days)
A patient examination Vinyl Powder Free Gloves is a disposable device Intended for medical patient and examiner. A patient examination vinyl in the is worn on the examiner' device Intended for medical patient and examiner.
Powder Free Vinyl Examination Glove
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Vinyl Examination Glove" and an "Indications for Use" statement.
This document does not contain information about the acceptance criteria and study results for an AI/device's performance as typically requested for medical AI devices. It details the FDA's decision regarding substantial equivalence for a medical glove, which is a physical device, not a software or AI-driven diagnostic tool.
Therefore, I cannot extract the requested information such as test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment, as this information is not present in 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.