Policies and Regulations

“Of gloves made from other materials, such as synthetic rubbers or polymers, "none possesses the unique mix of properties found in NRL [natural rubber latex] gloves."

-Medical Glove Powder Report, U.S. Food and Drug Administration
Updated 30 April 2009

 
Regulatory Requirements for Medical Gloves by the U.S. Food and Drug Administration (FDA)

Medical devices are some of the many items/products regulated by the FDA, a scientific, regulatory and public health agency that oversees about 25% of gross national products in the United States.

All medical gloves marketed in the U.S. are required by the FDA to be correctly labeled and cleared for marketing through a premarket notification submission [510(k)] prior to being distributed in the country. The FDA also requires manufacturers to produce gloves according to the Quality System (QS) regulation (known as Good Manufacturing Practices regulation earlier) to assure that gloves are produced at an acceptable quality level, thereby helping to assure their safety and effectiveness. The FDA believes that gloves worn by health care workers must provide an effective barrier to the transmission of infectious agents.

Medical gloves are classified by the FDA into one of three regulatory Classes: I, II and III as required by the Food Drug and Cosmetic Act. The class of a device determines the level of regulatory control that applies to it. Medical gloves are in Class I, but the FDA has proposed in 1999 that surgeon's gloves and patient examination gloves be reclassified into Class II, because it is thought the general controls in Class I are not sufficient to assure the glove safety and effectiveness. However, this proposal has not yet been finalized today.

Under the FDA regulations, medical gloves are subject to the following general controls:
  • Establishment Registration
  • Device Listing
  • Premarket Notification or 510(k) submission
  • Device Labeling
  • Quality System requirements (QS)
  • Medical Device Reporting (MDR)
All domestic and foreign medical glove manufacturers, distributors, repackers and other related agencies who wish to market their gloves in the United States are required to register, and list their products. The Premarket Notification (510k) includes a summary of information regarding the device, such as its "indication for use", its technological characteristics with measured parameters compared to ASTM (American Society for Testing and Materials) or equivalent standards; data showing compliance with FDA biocompatibility, pinhole, powder-free and other requirements and recommendations, as well as any labeling claims, for example: protein label claim and chemotherapy label claim. Clinical data is not needed for gloves cleared by the 510(k) process. For further information on general controls and compliance, please refer to:
 
Latex Gloves and Health Safety

Barrier of Choice in the U.S.

CDC : Glove use reduces infection rates

The Center for Disease Control and Prevention (CDC) recommends hand hygiene practices and glove use to prevent outbreaks in health care facilities, minimize transmission of antimicrobial resistant organisms, and reduce overall infection rates.
  • The CDC states that "gloves reduce hand contamination by 70 percent to 80 percent, prevent
    cross-contamination and protect patients and health care personnel from infection."
FDA: NRL glove is the barrier of choice



The following were selected statements from the US Food and Drug Administration (FDA) report entitled Medical Glove Powder Report, updated on 30 April 2009.
  • Natural rubber latex gloves are the barrier of choice in the U.S.
  • Of gloves made from other materials, such as synthetic rubbers or polymers, "none possesses the unique mix of properties found in NRL [natural rubber latex] gloves." These include high elasticity and tensile strength, and excellent film-forming characteristics.
  • NRL is pliable, allowing for natural molding for more appropriate fit and has the ability to reseal when tiny punctures occur.
  • In general, NRL provides comfort to the wearer, adequately protects against microorganisms, and provides adequate barrier effectiveness when used for medical and nursing procedures."
NIOSH & OSHA: Latex gloves aid barrier protection
  • Federal health agencies such as the National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) recommend the use of appropriate barrier protection, including the use of low-protein latex gloves, when handling infectious materials, (OSHA 2008).
 
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