(253 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
NITRILE EXAMINATION GLOVES ( POWDERED
The provided text is related to a 510(k) clearance letter from the FDA for "Nitrile Powdered Examination Gloves." It does not contain any information about acceptance criteria, device performance studies, or AI/software analysis.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the device, as none of this information is present in the provided document.
The document primarily focuses on the FDA's determination of substantial equivalence for the nitrile gloves to predicate devices and outlines regulatory responsibilities.
§ 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.