(131 days)
A 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.
POWDER FREE NITRILE EXAMINATION GLOVE
This document is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.
The letter is a regulatory document confirming that the gloves are substantially equivalent to a legally marketed predicate device. It discusses regulatory compliance, labeling, and other administrative details.
Therefore, I cannot provide the requested information based on 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.