(21 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
I am sorry, but the provided text only contains information about the FDA's clearance of "ENVIRON-NP Disposable Synthetic Vinyl Examination Gloves, Powdered" and does not include any details regarding acceptance criteria for a study, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.
The document is a 510(k) clearance letter, which means the device was found substantially equivalent to a legally marketed predicate device, rather than undergoing a new clinical study to establish acceptance criteria based on performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 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.