FDA Title 21 CFR 177.2600 Silicones
FDA Title 21 CFR 177.2600 silicones meet U.S. Food and Drug Administration (FDA) requirements for rubber articles intended for repeated use in contact with food. These requirements do not explicitly regulate medical devices. However, FDA Title 21 CFR 177.2600 establishes standards for material purity and low levels of extractables that are used for material selection in medical applications.
ElastaPro is a Made in USA manufacturer of FDA CFR 177.2600 silicones. We offer these materials as solid silicone sheets, continuous rolls, and uncured compound. Our medical grade silicones also meet USP Class VI, ISO 10993, and European Pharmacopoeia requirements. Contact us to request a quote or discuss your medical device or equipment application.
What is FDA Title 21 CFR 177.2600?
FDA Title 21 CFR 177.2600 is a U.S. regulation that’s designed to ensure harmful substances do not migrate into food or beverages during processing, packaging, or storage. It applies to rubber articles intended or repeated use in contact with food. However, FDA Title 21 CFR 177.2600 is frequently used by medical manufacturers as a basic benchmark.
It’s important to note that compliance with 21 CFR 177.2600 alone does not guarantee that a material is approved for all medical uses. As a regulatory agency, the FDA evaluates medical devices and equipment in their entirety, and not just individual component materials. That’s why medical grade silicones may also need to meet USP Class VI and ISO 10993 requirements.
Ask ElastaPro for FDA Title 21 CFR 177.2600 Silicones
Do you need FDA Title 21 CFR 177.2600 silicones? Contact ElastaPro for specifications grade solid silicone sheets, continuous rolls, and ready-to-mold compounds. Our medical grade elastomers meet FDA Title 21 CFR 177.2600, and they also comply with USP Class VI, ISO 10993, and European Pharmacopeia standards.
