(60 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED
This document is a 510(k) clearance letter from the FDA for Powdered Blue Nitrile Medical Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include performance data or studies that would detail acceptance criteria for a device's performance.
Therefore, I cannot extract the requested information from the provided text.
§ 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.