Search Results

Powdered Latex Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

Not Found

This document is a 510(k) clearance letter for "Top Glove Medical Powdered Latex Examination Gloves." As such, it's a regulatory approval document for a medical device (examination gloves), not a study report for an AI/ML diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies cannot be extracted from this document, as these concepts are specific to the evaluation of AI/ML diagnostic tools and are not applicable to the clearance of examination gloves.

The document primarily focuses on:

• Device Identification: Top Glove Medical Powdered Latex Examination Gloves, Regulation Number 880.6250, Product Code LYY.
• Regulatory Status: Substantially equivalent to legally marketed predicate devices, allowing the device to be marketed.
• Intended Use: Worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
• Compliance: Compliance with general controls provisions of the Act (registration, listing, GMP, labeling, etc.).

Ask a specific question about this device