(35 days)
A patient examination glove is a disposable device intended for medical purpose and A patient Exammation grovent contamination between health care personnel and the patient.
Polymer Coated Powder free latex examination gloves (with a protein label claim 50 MICKOGRAMS OR LESS
The provided text is a 510(k) premarket notification approval letter for "Polymer Coated Latex Medical Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)." This document is a regulatory approval and does not contain a study describing acceptance criteria, device performance metrics, or details of a clinical study for an AI-powered device.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement from the provided text. The document is strictly about the regulatory approval of a medical glove.
§ 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.