Search Results

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.

Ask a specific question about this device