(34 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.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Powdered Free Vinyl Synthetic Exam Gloves White Color." This document primarily addresses the substantial equivalence determination for a medical device and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications, as would typically be found in a study report or clinical trial documentation.
Therefore, I cannot provide the requested information based solely on the input provided. The document confirms the device's classification and allows its marketing but does not detail the technical performance or the studies behind it.
§ 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.