(46 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 Exam Glove, Blue Color
I am sorry, but the provided document does not contain the information requested regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a "Disposable Powder Free Vinyl Exam Glove, Blue Color". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. It does not include details about device performance metrics, study designs, sample sizes, or expert qualifications.
§ 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.