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Zdrowie i gospodarka · 24.06.1996

Latex-containing Devices; User Labeling

The Food and Drug Administration (FDA) is proposing to amend the regulations to require all medical devices containing natural rubber latex that may directly or indirectly contact living human tissue to be labeled with a statement identifying the product as one which contains natural rubber latex and which may cause allergic reactions. The agency is also amending the regulation to require that hypoallergenicity claims be removed from latex medical gloves and other natural rubber latex medical devices because the modified human Draize test currently used to support hypoallergenicity claims addresses only chemical sensitivity, and it is inappropriate for determining protein sensitivity in humans. These requirements are being proposed in response to numerous reports that have been received of severe allergic reactions to a wide range of medical devices containing natural rubber latex.

Source: Federal Register — Food and Drug AdministrationOpen original release →