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FDA is concerned that statements submitted for inclusion in medical product labeling
such as ''latex-free,'' ''does not contain natural rubber latex,'' or ''does not contain latex''
are not accurate because it is not possible to reliably assure that there is an absence of the allergens
associated with hypersensitivity reactions to natural rubber latex in the medical product.
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submit written or electronic comments on the draft guidance by June 10, 2013