(108 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Matang Powder-Free Latex Patient Examination Glove, with Protein Labeling Claim (50 Micrograms or Less)
This document is a 510(k) premarket notification from the FDA, approving the marketing of Matang Powder-Free Latex Patient Examination Gloves with a protein labeling claim. It does not contain the detailed study information typically requested for AI/ML device evaluations. Therefore, I cannot provide the specific information requested in the prompt based on this document.
The document primarily focuses on the regulatory approval process for a medical device (latex gloves) and confirms its substantial equivalence to a legally marketed predicate device. It does not include data from a study on device performance against specific acceptance criteria in the way an AI/ML device submission would.
To answer your prompt, I would need a document that presents the results of a study designed to demonstrate the performance of a device (likely an AI/ML device) against predefined acceptance criteria.
§ 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.