“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
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 productsin the United States.
All medical gloves marketedin 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:
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: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
The following were selected statements from the US Food and Drug Administration (FDA) report entitled Medical Glove Powder Report, updated on 30 April 2009.
The FDA has assumed a leading role in regulating the marketing and use of medical gloves. At the onset of the latex protein allergy problem in the 1990s, the FDA took the following measures:
In 1997, NIOSH developed a safety Alert entitled, "Preventing Allergic Reactions to Natural Rubber Latex in the Workplace." The Alert recommended the use of reduced protein content powder-free gloves when latex gloves were used for effective barrier protection against infections and minimum exposure to latex proteins at work places.
OSHA, under the U.S. Department of Labor, was involved in setting guidelines for health care workers through a Technical Information Bulletin on April 12, 1999, entitled, "Potential for Allergy to Natural Rubber Latex Gloves and other Natural Rubber Products."
It is now apparent that the cause of latex protein sensitization and allergic reactions of sensitive individuals is attributed to the use of an older generation of latex gloves with no control their protein and powder levels. Advancements in latex glove manufacturing technologies have now led to the production of low-protein, lightly powdered or powder-free latex gloves. The use of these gloves has in fact been shown by a number of recent independent hospital studies to vastly reduce the incidence of latex sensitization and reactions in workplaces. The studies also showed that latex allergic individuals donning synthetic gloves can work alongside co-workers wearing latex gloves without having allergic reactions. To review these studies, go to Hospital Studies
The advent of these improved low-protein/allergen gloves enables the majority of healthcare professionals who are not latex allergic to continue to rely on the superior barrier protection that latex gloves provide. This is not withstanding the fact that latex gloves are also known to offer excellent comfort, fit, tactile sensitivity, and durability - critical glove characteristics that manufacturers of many synthetic gloves are attempting to achieve.
However, in the absence of any regulatory requirements by the FDA limiting glove protein levels, latex gloves with high protein and powder content are still available in the marketplace. Precautions must be taken by healthcare personnel to select the right latex gloves - those that are high-quality, low-protein and lightly powdered or powder-free.
As the FDA is still deciding whether or not to finalize its 1999 proposed rule for medical devices, OSHA is in the process of revising its 1999 guidelines in the Technical Information Bulletin.
On December 10, 2003, the Consumer Product Safety Commission held a hearing on a petition to declare natural rubber latex a strong sensitizer and to require latex products to be labeled as such. The Commission concluded that "the information currently available is not sufficient to begin a rulemaking proceeding to declare NRL a strong sensitizer." Click here to view a copy of the denial letter and statement issued by CPSC Commissioner Thomas H. Moore filed June 4, 2004.