6/20/2023 0 Comments Medical tape allergy![]() (i) Any affected person may request an exemption or variance from the requirements of this section by submitting a citizen petition in accordance with § 10.30 of this chapter. (h) Devices that contain natural rubber that contacts humans, as described in paragraph (b) of this section, shall not contain the term "hypoallergenic" on their labeling. "The Packaging of This Product Contains Dry Natural Rubber." (g) Devices that have packaging containing dry natural rubber that contacts humans, as described in paragraph (b) of this section, shall bear the following statement in bold print on the device labeling: This statement shall appear on the packaging that contains the natural rubber, and the outside package, container, or wrapper. "Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions." (f) Devices that have packaging containing natural rubber latex that contacts humans, as described in paragraph (b) of this section, shall bear the following statement in bold print on the device labeling: "This Product Contains Dry Natural Rubber." (e) Devices containing dry natural rubber that contacts humans, as described in paragraph (b) of this section, that are not already subject to paragraph (d) of this section, shall bear the following statement in bold print on the device labeling: This statement shall appear on all device labels, and other labeling, and shall appear on the principal display panel of the device packaging, the outside package, container or wrapper, and the immediate device package, container, or wrapper. "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions." (d) Devices containing natural rubber latex that contacts humans, as described in paragraph (b) of this section, shall bear the following statement in bold print on the device labeling: ![]() ![]() Each required labeling statement shall be prominently and legibly displayed in conformance with section 502(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. (c) Devices containing natural rubber shall be labeled as set forth in paragraphs (d) through (h) of this section. This includes contact when the device that contains natural rubber is connected to the patient by a liquid path or an enclosed gas path or the device containing the natural rubber is fully or partially coated with a powder, and such powder may carry natural rubber proteins that may contaminate the environment of the user or patient. (3) The term "contacts humans" means that the natural rubber contained in a device is intended to contact or is likely to contact the user or patient. Products are formed from dry natural rubber by compression molding, extrusion, or by converting the sheets into a solution for dipping. (2) The term "dry natural rubber" means rubber that is produced by the dry natural rubber process that involves the use of coagulated natural latex in the form of dried or milled sheets. Products are formed from natural rubber latex by dipping, extruding, or coating. (1) The term "natural rubber latex" means rubber that is produced by the natural rubber latex process that involves the use of natural latex in a concentrated colloidal suspension. The term "natural rubber" includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation. (b) This section applies to all devices composed of or containing, or having packaging or components that are composed of, or contain, natural rubber that contacts humans. This labeling regulation is intended to minimize the risk to individuals sensitive to natural latex proteins and protect the public health. ![]() (a) Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. 801.437 User labeling for devices that contain natural rubber. Subpart H - Special Requirements for Specific Devices The information on this page is current as of Mar 28, 2023.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). ![]()
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