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U.S. Department of Health and Human Services

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There's No Guarantee of 'Latex Free'

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Latex Glove Lab Test

Natural rubber latex is used in the manufacture of various FDA-regulated products, such as condoms and medical gloves. Here, a physical science technician inspects medical gloves in related integrity testing at an FDA laboratory in Irvine, CA. For this and other FDA photos, go to Flickr.

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To avoid giving a false sense of security to people who are allergic to natural rubber latex, the Food and Drug Administration (FDA) is recommending that manufacturers of FDA-regulated medical products stop using statements on labels such as "latex-free" or "does not contain latex."

The problem with that language is that FDA is aware of no tests that can show a medical product is completely without the natural rubber latex proteins that can cause allergic reactions. Without a way to verify that a product is free of these proteins, claims that a product is "latex free" may be misleading. FDA wants to promote scientifically accurate labeling.

As a result, FDA is recommending in a draft guidance document announced in the Federal Register on March 8, 2013 that manufacturers who want to indicate that natural rubber latex was not used as a material instead use the more scientifically accurate labeling statement "not made with natural rubber latex." Public comments are welcome. Details on how to submit comments are provided in the draft guidance document and Federal Register notice.

Natural rubber latex made from plant sources such as the sap of the Brazilian rubber tree or its synthetic derivatives is used in numerous medical products, including adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches and blood-pressure monitoring cuffs. Repeated exposure can result in sensitivity to natural rubber latex proteins, with symptoms ranging from skin redness, rash, hives or itching to difficulty breathing and wheezing. Rarely, shock and even death can occur.

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Who is at Risk?

Since sensitivity is more likely to build up over time, those at highest risk are those who frequently wear latex gloves, including health care workers. "It is not possible to predict in advance just how much exposure to natural rubber latex might be needed to sensitize any specific person," said Sheila A. Murphey, M.D., a medical officer in FDA's Center for Devices and Radiologic Health (CDRH).

The Occupational Health and Safety Administration (OSHA) estimates that 8 to 12 percent of health care workers are latex-sensitive. Workers in plants that produce natural rubber latex or that manufacture products containing natural rubber latex might also be at greater risk. OSHA also estimates that 1 to 6 percent of the general population may be sensitive to natural rubber latex.

OSHA and the Centers for Disease Control and Prevention (CDC) recommend the following steps to prevent allergic reactions to natural rubber latex in the workplace:

  • Avoid using gloves with natural rubber latex for activities that are unlikely to involve contact with infectious materials.
  • If you need such gloves, use powder-free gloves labeled as having reduced protein content, and when wearing them, do not use oil-based lotions. Natural rubber latex proteins can become attached to powder used to lubricate gloves and when the gloves are removed, the particles become airborne and can be inhaled, which is another form of exposure. Oil-based lotions can cause deterioration of the gloves.
  • After use, wash your hands with a mild soap and dry thoroughly.
  • Learn to recognize the symptoms of a natural rubber latex allergy and take any training offered by your employer.

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The Danger of Inaccurate Labeling

FDA requires manufacturers to label certain regulated products stating that they are made of natural rubber latex, including medical gloves and condoms. However, when natural rubber latex is not used as a material, medical product manufacturers are not required to state this in the product labeling. In these cases, some manufacturers use statements on the label like "latex-free."

Such labeling statements are not supported by scientific evidence and overlook the fact that the products could have been contaminated with natural rubber latex allergens when they were manufactured or packaged.

In addition, statements such as "latex free" that are not specific about the type of latex being referred to can cause confusion. Not all types of latex contain the proteins responsible for natural rubber latex allergy. For example, products containing nitrile and polyvinyl chloride are made of synthetic latex that does not contain those proteins.

FDA guidance documents are recommendations. The intent of this draft guidance is to promote consistent, scientifically accurate language for health care professionals, patients and consumers who want to avoid natural rubber latex.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

March 8, 2013

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