(85 days)
A Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent device in between patient and examiner.
Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)
The provided text is a 510(k) premarket notification letter from the FDA regarding "Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)". This document primarily deals with regulatory approval based on "substantial equivalence" to a legally marketed predicate device.
It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.
Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria and performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training). The document is a regulatory approval letter, not a scientific study report.
§ 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.