(75 days)
A PATIENT EXAMINATION GLOVES 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.
Disposable Powder Free Vinyl Synthetic Exam Glove, White Color
The provided text is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Vinyl Synthetic Exam Glove, White Color. This document does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of a medical imaging or AI-powered diagnostic device, which is what your questions are geared towards.
The document is an approval letter for a medical glove, which falls under general controls and does not require complex performance studies like those for diagnostic devices. Therefore, I cannot extract the information you requested about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement, as these concepts are not applicable to the content of this specific regulatory document for a medical glove.
§ 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.