(30 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Not Found
The provided text is a 510(k) premarket notification for "Ultra Touch Powdered Latex Examination Gloves, with Protein Labeling Claim (120 Micrograms or Less)". This document is a regulatory approval letter from the FDA, and it does not contain information about acceptance criteria or a study proving device performance.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would typically be detailed for a novel device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC comparative effectiveness studies from 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.