Formulated to meet the material safety requirements of 21 CFR 177.2600, the U.S. Food & Drug Administration regulation governing rubber articles intended for repeated food contact.
The SSP2390 Series is a family of platinum-cured FDA silicones ranging from 10 to 80 durometer (Shore A). Engineered for extreme purity, these materials meet 21 CFR 177.2600 requirements governing rubber articles intended for repeated food contact.
SSP’s FDA silicones offers a combination of mechanical, thermal, and chemical properties ideal for hygienic environments.
Flexible across wide temperature ranges
Excellent compression set resistance
High tear strength options available
Suitable for both hot and cold processing
Stable under repeated sterilization cycles
Resistant to thermal aging
Compatible with CIP/SIP cleaning chemicals
Resistant to oils, fats, and mild acids
Non‑reactive with food products
The table below summarizes key differences between food grade silicones and general purpose silicones.
| Property | Food Grade Silicone | General Purpose Silicone |
|---|---|---|
| Regulatory Compliance | 21 CFR 177.2600 | None |
| Extractables | Low | Variable |
| Purity | High | Standard |
| Food Contact Safety | Yes | No |
| Typical Applications | Food, beverage, pharma | Industrial, automotive |
Food grade silicone is not automatically medical‑grade; however, the SSP2390 series are also medical silicones.
| Feature | Food Grade Silicone | Medical Grade Silicone |
|---|---|---|
| Governing Standard | 21 CFR 177.2600 | USP Class VI |
| Intended Use | Food, beverage, dairy, pharma processing | Short-term implants, medical devices, biocompatible components |
| Purity Level | High | Highest |
| Extractables | Controlled | Extremely low |
| Typical Forms | Gaskets, tubing, seals | Tubing, molded components |
FDA silicones are used across industries where sanitation, durability, and regulatory compliance are critical.
Pump and valve seals
Transfer tubing
Oven and freezer gaskets
Bottling and filling equipment
Dairy processing components
Peristaltic pump tubing
Sanitary gaskets
Fluid‑handling seals
Cleanroom equipment components
Food‑safe bakeware
Beverage dispensing systems
Water filtration components
SSP’s FDA silicones are platinum-cured for high purity. However, both platinum‑cure and peroxide‑cure systems can be FDA‑compliant, provided they meet extractables limits.
Silicones that are FDA compliant meet 21 CFR 177.2600 requirements that govern rubber articles intended for repeated food contact.
No. FDA approved silicones have been thoroughly tested to FDA standards by an FDA agent or expert.
Yes — 21 CFR 177.2600 specifically covers repeated‑use food contact applications.
Most FDA silicones operate from –60°C to +200°C, with specialty grades available for higher temperatures.
Yes — it withstands common sanitizers, detergents, and CIP/SIP processes.
Compliance applies to the material formulation, not the final geometry.
Technical Specialist, Specialty Silicone Products, Inc.
Last Updated: April 2026