(133 days)
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON-THE EXAMINER*S WAND TO PREVENT CONTAMINATION™ BETWEEN PATIENT AND EXAMINER.
POWDER-FREE LATEX EXAMINATION GLOVES
The provided text is a 510(k) premarket notification letter from the FDA regarding "Latex Examination Gloves, Powderfree." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail performance acceptance criteria or a study's findings.
§ 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.