(46 days)
A medical glove is wom on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Omni Touch Nitrile Examination Glove, Powdered, Blue
This document is a 510(k) clearance letter from the FDA for a medical device: "Omni Touch Nitrile Examination Glove, Powdered, Blue." It signifies that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, device performance data, study details (sample size, provenance, expert qualifications, adjudication, MRMC studies, standalone performance), or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is a regulatory approval, not a scientific study report.
§ 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.