(79 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 & examiner.
Not Found
This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, but this refers to regulatory equivalence based on intended use and technological characteristics, not performance against specific criteria.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from 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.