FDA-approved silicone rubber is a high-quality, non-toxic material used in food processing and medical applications. It meets strict FDA compliance standards for direct contact with food, beverages, and pharmaceuticals. Silicone rubber is valued for its durability, flexibility, and resistance to extreme temperatures, and it is ideal for seals, gaskets, and tubing in various industries.
As a leading rubber product manufacturer, we provide high-quality, FDA-approved silicone solutions for food, medical, and industrial applications.
In this blog, you will learn about FDA-approved silicone rubber, its properties, manufacturing process, applications, and how to choose the right profile for your needs.
What is FDA Approved Silicone Rubber?
FDA-approved silicone rubber is a nontoxic, high-purity material that meets FDA 21 CFR 177.2600 regulations. It is safe for direct contact with food, beverages, and medical applications.
Due to its durability, flexibility, and resistance to extreme temperatures and chemicals, rubber is widely used in the food processing, pharmaceutical, and healthcare industries. It is also safe for sensitive environments in seals, gaskets, and tubing.
What are the Properties of FDA-Approved Silicone Rubber?
FDA-approved silicone rubber is known for its high durability, safety, and versatility in food, medical, and industrial applications.
| Property of FDA-Approved Silicone Rubber | Description |
| High-Temperature Resistance | Handles -60°C to 250°C, ideal for high-temperature applications. |
| Thermal Stability | Maintains flexibility and strength under extreme heat or cold. |
| Biocompatibility & Medical Safety | Non-toxic, hypoallergenic, used in medical tubing and surgical equipment. |
| Durability & Chemical Resistance | Resists moisture, chemicals, and wear, ensuring long-lasting performance. |
| Flexibility & Elasticity | Maintains sealing properties under mechanical stress and pressure. |
| Electrical & Thermal Conductivity | Standard silicone is an electrical insulator, while conductive silicone is used for special applications. |
How is the Manufacturing Process & Quality Control Maintained?
FDA-approved silicone rubber undergoes a precise manufacturing process to meet strict safety and performance standards.
From material selection to final product testing, each step has compliance, durability, and high-quality output for food, medical, and industrial applications.
1. Custom Silicone Rubber Parts & Fabrication
The manufacturing process begins with selecting food-grade or medical-grade silicone rubber. The material is then molded, extruded, or cast into custom silicone rubber parts, including seals, gaskets, and tubing.
- Extrusion
Used for creating continuous profiles like silicone sponge gaskets and tubing. - Molding
Ideal for producing complex Rubber O-rings and custom silicone seals. - Die-cutting
Ensures precision in flat gaskets and sealing components.
2. Testing for FDA & USP Class VI Compliance
To be FDA-approved, silicone rubber must pass strict regulatory tests that confirm its safety for food contact and medical applications.
One of the highest standards is USP Class VI certification, which certifies that the material is biocompatible, non-toxic, and free from harmful chemicals.
- USP Class VI Testing
Verifies that the material does not cause toxicity or irritation when used in medical or pharmaceutical applications. - FDA 21 CFR 177.2600 Compliance
Silicone rubber is safe for food and beverage applications.
3. High-Quality Gasket & Seals Production
Quality control guarantees consistent performance and safety.
Every batch of FDA-approved silicone rubber undergoes rigorous testing and inspection before reaching customers.
- Physical & Mechanical Testing
Evaluates tensile strength, tear resistance, and elasticity. - Thermal & Chemical Resistance Checks
Ensures durability in high-temperature and harsh environments. - Dimensional Accuracy & Precision Cutting
It guarantees proper sealing and fitment in gaskets and Rubber O-rings.
Following these strict manufacturing and quality control measures, FDA-approved silicone rubber maintains high reliability in food processing, medical, and industrial applications.
What are the Types of FDA-Approved Silicone Rubber Profiles?
FDA-approved silicone rubber is available in different forms to suit various food, medical, and industrial applications.
Each type serves a specific purpose: safety, durability, and compliance with strict regulations.
1. O-Rings & Seals for FDA-Approved Applications
FDA-approved O-rings and seals are widely used in food processing, pharmaceuticals, and medical equipment to prevent leaks and contamination.
These rubber seals are designed for high temperatures, chemicals, and frequent cleaning cycles.
Common Uses
- Food machinery seals for processing liquids and dry ingredients
- Medical device sealing to maintain sterile environments
- Industrial processing equipment that requires leak-proof performance
2. Silicone Tubing & Rubber Hosing for Food & Medical Use
Silicone tubing and rubber hosing are industries that require hygienic fluid transfer.
FDA-approved silicone tubing is non-toxic, flexible, and resistant to high temperatures and chemicals, making it ideal for food and beverage manufacturing, pharmaceutical processes, and medical applications.
Common Uses
- Food-grade tubing for transferring liquids, syrups, and dairy products
- Medical tubing for IV lines, surgical tools, and lab equipment
- Rubber hosing for beverage dispensing systems
3. Conductive & Metal Detectable Silicone for Safety Compliance
Specialized conductive and metal-detectable silicone is used in industries where safety and contamination prevention are top priorities.
Electrically detectable silicone tubing allows any broken fragments to be identified through metal detectors in food processing facilities, preventing contamination. Conductive silicone is used in industrial and electronics applications where electrical conductivity is required.
Common Uses
- Metal-detectable silicone seals in food production to prevent contamination
- Conductive silicone components for medical devices and industrial applications
- FDA-approved gaskets for high-safety environments
What are the Applications of FDA-Approved Silicone Rubber?
Due to its durability and safety, FDA-approved silicone rubber is used in food processing, pharmaceuticals, aerospace, and industrial sealing applications.
| Industry | Applications of FDA-Approved Silicone Rubber |
| Food Processing & Manufacturing | Used in seals, gaskets, tubing, and conveyor belts for food contact surfaces. Maintains hygiene and handles high temperatures. |
| Medical & Pharmaceutical | Surgical tubing, IV lines, catheters, and medical seals due to its biocompatibility, sterility, and non-toxic properties. |
| Aerospace & Automotive | High-temperature seals, gaskets, and insulating components for extreme environments and durability. |
| Industrial & Manufacturing | Chemical-resistant gaskets, hoses, and vibration dampers for heavy-duty machinery. |
| Electronics & Electrical | Conductive silicone parts, heat-resistant insulators, and protective seals for electrical equipment. |
Sustainability & Environmental Impact of FDA-Approved Silicone Rubber
FDA-approved silicone rubber is long-lasting and non-toxic, making it safer for food and medical applications. While not biodegradable, it is more environmentally friendly than many plastics, as it does not release harmful chemicals.
Silicone rubber is stable, reusable, and does not break into microplastics. Compared to disposable plastics, it has a lower environmental impact.
Silicone can be recycled through specialized facilities. Used food-safe tubing and rubber components can sometimes be repurposed. EPDM rubber, though food-safe, differs in properties and recyclability.
Why Choose Elastostar Rubber Corporation for Quality & Compliance?
Elastostar Rubber Corporation is a trusted manufacturer of FDA-approved silicone rubber products. It provides high-quality seals, gaskets, and tubing for food, medical, and industrial applications.
Our materials are tested and certified to meet USP Class VI and Section 88 and 87 compliance for safety and reliability. We are committed to high standards, durability, and custom solutions using FDA-compliant silicone that meets strict regulations.
Do you need FDA-approved seals, medical-grade tubing, or custom parts? Contact us for the best solutions for your industry.
Recommended Reads
- Medical-Grade Silicone: Meaning & Applications
- Top Applications of FDA Silicone Rubber in Food Processing Industries
- How to Differentiate Between Food-Grade FDA Silicone Rubber & Regular Silicone
Conclusion
FDA-approved silicone rubber is a safe, durable, and versatile material widely used in food processing, medical, and industrial applications. It meets strict FDA and USP Class VI standards, making it suitable for direct contact with food and medical devices.
High-temperature resistance, flexibility, and chemical stability provide long-lasting performance in demanding environments.
Available in various forms, including O-rings, seals, tubing, and gaskets, it maintains hygiene, safety, and efficiency across industries. Choosing the right silicone rubber profile compliance and reliability in critical applications.
FAQs
Is silicone rubber FDA-approved?
Yes, FDA-approved silicone rubber meets FDA 21 CFR 177.2600 regulations, making it safe for direct food, beverage, and medical contact. It is widely used in food processing, pharmaceuticals, and medical devices.
What is the ASTM standard for silicone rubber?
The ASTM D2000 standard classifies silicone rubber based on its physical, chemical, and performance properties, ensuring suitability for industrial and medical applications.
What is medical-grade silicone rubber?
Medical-grade silicone rubber is biocompatible, non-toxic, and meets USP Class VI standards. It is used in medical tubing, surgical devices, and pharmaceutical applications. Elastostar Rubber Corporation offers high-quality FDA and USP Class VI-compliant silicone rubber solutions.
Is Viton FDA-approved?
Some Viton® (FKM) rubber grades are FDA-approved for food and pharmaceutical use, but standard Viton may not be compliant for direct food contact. For FDA-certified Viton or silicone rubber products, explore Elastostar’s silicone rubber solutions.
How to identify silicone rubber?
Silicone rubber is soft, flexible, and heat-resistant, with excellent chemical stability. Unlike regular rubber, it does not degrade, crack, or harden over time.
Is EPDM rubber FDA-approved?
Not all EPDM rubber is FDA-approved. Only FDA-compliant EPDM meets food and medical safety requirements. For high-quality FDA-approved rubber seals and gaskets, contact Elastostar Rubber Corporation.
