SSP makes FDA silicone materials for food contact and medical applications. Our SSP2390 series elastomers also meet USP Class VI and RoHS requirements. They are platinum-cured for low levels of extractables.
What is FDA Silicone?
FDA silicone refers to a type of silicone that meets the safety and quality standards set by the U.S. Food and Drug Administration (FDA) for use in applications that involve contact with food, beverages, pharmaceuticals, or the human body.
FDA silicone must comply with FDA 21 CFR 177.2600, which is the regulation for rubber articles intended for repeated use in food contact. Otherwise, a silicone is not an FDA approved silicone.
What is FDA 21 CFR 177.2600?
FDA 21 CFR 177.2600 specifies the requirements for rubber articles intended for repeated use that come into contact with food. This regulation ensures that such materials are safe and do not transfer harmful substances to food.
Key Features of FDA Silicone
Biocompatible: Safe for use in medical and food-contact applications.
Non-toxic & Odorless: Won’t leach harmful substances.
Heat Resistant: Can typically withstand temperatures from -60°C to 230°C (-76°F to 446°F), sometimes higher.
Flexible & Durable: Maintains elasticity and integrity over time.
Non-reactive: Chemically inert, so it won’t interact with the contents it touches.
Easy to Sterilize: Can be cleaned with steam, boiling, or certain chemicals.
Common Uses for FDA Approved Silicone
- Food-grade tubing and seals
- Baby bottle nipples and pacifiers
- Bakeware and kitchen utensils
- Medical tubing, implants, and gaskets
- Pharmaceutical manufacturing components
Who Makes FDA Silicone?
SSP2390 meets FDA 21 CFR 177.2600 requirements from the U.S. Food and Drug Administration (FDA), a regulatory agency. FDA 21 CFR 177.2600 specifies the requirements for rubber articles intended for repeated use that come into contact with food. This regulation ensures that such materials are safe and do not transfer harmful substances to food.
SSP2390 Silicones
SSP2390 silicones are high-purity elastomers for medical devices, medical equipment, and food-contact applications. Because they are platinum-cured, these materials have stronger physical properties and lower shrinkage values than peroxide cured compounds.
SSP ships these silicones platinum pre-catalyzed and ready for use. Choose moldable compounds, sheet stock, or rolls from .005″ to .250″ thick. Among its many advantages, SSP2390 is available in a range of durometer-based grades (10 to 80 Shore A).
