(312 days)
A patient examination Powdered Nitrile Blue Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
POWDERED NITRILE BLUE EXAMINATION GLOVE
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a "Powered Nitrile Blue Examination Glove." It does not contain information about the acceptance criteria, study details, or performance of a device in the context of an AI/medical device study.
The document is purely a regulatory letter stating that the device is substantially equivalent to legally marketed predicate devices and outlines the regulations the manufacturer must comply with.
Therefore, I cannot extract the requested information from the given 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.