(63 days)
A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
NITRILE BLUE POWDER FREE EXAMINATION GLOVE
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Nitrile Blue Powder Free Examination Glove. It is a regulatory document and does not contain information about the acceptance criteria, study details, or performance of a device in the context of AI/ML or medical imaging analysis as implied by your detailed request.
The document discusses:
- The FDA's review of a premarket notification for a medical glove.
- The determination of substantial equivalence to a legally marketed predicate device.
- General controls and regulations applicable to the device.
- The intended use of the glove as a disposable device to prevent contamination between patient and examiner.
Therefore, I cannot extract the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in 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.