(32 days)
A Medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and patient.
NITRILE LATEX EXAMINATION GLOVES, POWDERFREE
The provided text is a 510(k) premarket notification letter from the FDA to Innovative Gloves Company, Ltd. regarding their Nitrile Examination Gloves, Powderfree. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Instead, it's a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It references an "Indications for Use" enclosure (which is provided in the third image) but does not detail the technical performance or testing methodology.
Therefore, I cannot extract the requested information from the provided text because it is not present.
§ 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.