(53 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Tekmedic Powder-Free Latex Examination Gloves, with Protein Labeling Claim (50 Micrograms or Less)
The provided text describes a 510(k) premarket notification for "Tekmedic Powder-Free Latex Examination Gloves With Protein Content Labeling Claim (50 Micrograms or Less)." This document is a regulatory approval, not a scientific study describing acceptance criteria and device performance.
Therefore, I cannot provide the requested information as the input does not contain a study detailing acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies. The document is solely an FDA approval letter based on substantial equivalence to a predicate device.
§ 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.