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FDA: ‘Latex-free’ claims for medical products may be misleading

March 13, 2013

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Washington – The Food and Drug Administration is recommending that manufacturers of medical products stop using the claims “latex-free” and “does not contain latex,” saying the claims may be inaccurate.

According to a draft guidance document (.pdf file) issued March 11, FDA is not aware of any tests that can verify a product is completely free of natural rubber latex proteins, which can trigger an allergic reaction in latex-sensitive people. Even products that are not made from latex can be contaminated during the manufacturing or packaging process, FDA warns.

To avoid giving people a false sense of security, FDA advises manufacturers to use the statement “not made with natural rubber latex.”

Between 8 and 12 percent of health care workers are sensitive to latex, according to OSHA.

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