(85 days)
The device is a disposable synthetic rubber examination glove intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner.
Not Found
This document is a 510(k) clearance letter for Powder Free, Sterilized, Polychloroprene Examination Gloves. It focuses on the regulatory approval of the device and does not contain information about acceptance criteria or a study proving its performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which means that its performance is presumed to be similar to existing approved devices.
Therefore, I cannot provide the requested information based on this document.
§ 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.