(378 days)
A 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.
Jiatai Synthetic Vinyl Exam Gloves, Powdered, USP
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shanghai Jiatai Plastic Products Company, Limited regarding their Pre-Powdered Non-Sterile Vinyl Examination Gloves.
This document confirms that the device has been found substantially equivalent to a predicate device and allows it to be marketed. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on 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.