(64 days)
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or less)
This is a 510(k) premarket notification for "Superqloves Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less)". This document is an FDA clearance letter and not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. The "Indications For Use" section describes the intended purpose of the gloves, but not specific performance metrics or the studies used to demonstrate them.
To answer your questions, if such a study was performed, it would be found in the manufacturer's submission to the FDA, which is not publicly available in this document.
§ 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.