|User Facility Reporting Bulletin||Spring 1997|
HOW FDA REGULATES GLOVESby Terrell A. Cunningham, R.N.
Good Manufacturing Practices. Manufacturers of medical gloves are required to meet Good Manufacturing Practices (GMPs) for medical devices. The GMP regulation requires that every manufacturer prepare and implement a quality assurance (QA) program that is appropriate for the type of glove being manufactured. QA programs specify such items as proper cleaning and maintenance of equipment; monitoring and control of the manufacturing process; and identification of specific glove defects, their causes, and any actions necessary to correct the problem. Also, part of the GMP compliance requires manufacturers to test their gloves to make sure they meet the acceptable quality level (AQL) and quality claims when delivered to customers.
Required Labeling. All medical gloves must be labeled with specific information. Examples of the type of labeling required on glove packaging include country of origin and adequate directions for use. In June 1996, a proposed rule for latex content labeling was issued. When this proposed rule becomes final, all manufacturers of latex-containing products will be required to provide latex content information on their product label.
Special Labeling Claims. In addition to required labeling, manufacturers may label gloves with claims of special attributes such as color, thickness, absence of powder, and latex content. Claims for these attributes must meet certain specifications or guidelines as outlined in FDA guidance or recognized industry standards. Manufacturers must submit data to FDA to support these labeling claims, and all claims must be cleared before marketing.
Surveillance Sampling. FDA inspects samples of gloves at the port of entry into the United States using the water leak test method. Even though some imported gloves may have passed the water leak test at the manufacturing site, the gloves may not pass the same test once they reach the U.S. If they fail the U.S. testing, the gloves cannot be sold. Sample lots of gloves manufactured in the U.S. are also periodically tested by FDA using the water leak test method.
Stability and Expiration Dating. Gloves from some manufacturers have longer stability than others. To help reduce this problem, FDA asked the American Society for Testing and Materials (ASTM) to modify its standards to require initial testing and periodic follow-up testing to verify that gloves will pass the water leak test after accelerated or real-time aging. In 1995, ASTM began to study the degradation of gloves in order to assess and improve existing standards.
FDA is conducting a feasibility study to determine whether or not using an accelerated aging test can predict the shelf life of medical gloves. Currently, if a manufacturer wants to put an expiration date on the label, FDA requires real-time aging of medical gloves to support the expiration date. FDA is also evaluating the environmental degradation of natural rubber latex (NRL) gloves.
Guidance to Manufacturers. FDA has produced guidance documents such as “Guidance for Medical Gloves: A Workshop Manual” to help manufacturers meet FDA requirements and to improve the quality of medical gloves in the marketplace. FDA also conducts training courses that encourage manufacturers to improve the overall quality of medical gloves by complying with voluntary ASTM standards and equivalent international standards.
Medical Device Reporting. FDA has both mandatory and voluntary systems for reporting of adverse incidents with medical devices. Manufacturers and device distributors are required to report to FDA when they become aware of any device-related death, serious injury, or malfunction that could cause serious injury if the malfunction were to recur. User facilities are required to report device-related deaths to FDA and the manufacturer and serious injuries to the manufacturer. Healthcare professionals and consumers may report any device-related concern to FDA through the MedWatch Program by calling 1-800-FDA-1088. FDA monitors adverse event reports related to medical gloves and reviews and acts upon them as appropriate.
Terrell Cunningham is a nurse consultant in CDRH’s Office of Device Evaluation.
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