A Complete Guide to FDA Approved Silicone Rubber
What is FDA Approved Silicone Rubber?
FDA approved silicone rubber is a general purpose silicone that meets the stringent safety and compliance standards set by the US Food and Drug Administration (FDA). It is specifically formulated for applications that require direct or indirect contact with food, beverages, pharmaceuticals or other consumables. This material offers the same inherent benefits of silicone rubber—thermal stability, flexibility and chemical resistance—while ensuring it is safe for use in sensitive environments.
Composed of silicon-oxygen polymer chains, FDA approved silicone rubber is chemically inert, non-toxic and free of harmful additives that could contaminate consumables. Its ability to withstand high and low temperatures, coupled with its resistance to microbial growth, makes it a preferred choice in industries such as healthcare, food processing and biotechnology.
Appearance
Initially translucent but can be pigmented to any RAL colour.
Tear Strength
Resistance
to tearing around 26N/mm.
Density
Formulated
for a density of between 1.5 g/cm3 and 1.2g/cm3.
Hardness
Available
between 24ᵒ Shore A and 79ᵒ Shore A.
Tensile Strength
Tensile
strength between 9N/mm2 and 10N/mm2.
Elongation at Break
Flexibility
between 420% and 920% without breaking.
Temperature Range
Operates
effectively between -50°C and 180°C.
Rebound Resilience
Recovery
from deformation between 42% and 53%.
Learn how FDA approved silicone is formulated, how it differs from specialist grades and common applications within the industry.
How is FDA Approved Silicone Rubber Made?
The production of FDA approved silicone rubber begins with the synthesis of polydimethylsiloxane (PDMS), a silicon-based polymer derived from silica sand. This base polymer is then combined with reinforcing fillers, such as fumed silica, to enhance its mechanical properties. The formulation is carefully controlled to ensure compliance with FDA regulations, which require the absence of harmful substances and ensure biocompatibility.
FDA approved silicone rubber is cured to eliminate residual by-products that could pose contamination risks. During the vulcanisation process, the material is heated and cross-linked, creating a durable elastomer with the desired flexibility, strength and thermal stability. The curing agents and additives used are meticulously selected to ensure the material meets FDAs standards for food-grade or medical-grade applications.
After vulcanisation, the silicone rubber undergoes rigorous testing for purity, biocompatibility and physical performance. Common tests include assessments for extractables and leachables, which ensure that no harmful substances migrate into consumables during use. Compliance with FDA standards is verified through certification processes allowing OEMs to market their products as safe for regulated applications.

Advantages of FDA Approved Silicone Rubber
FDA approved silicone offers several key advantages that make it indispensable for sensitive applications. One of its primary benefits is its non-toxic and biocompatible nature, which ensures it can be safely used in environments where contamination risks must be minimised. This property is especially important for medical devices, food contact applications and pharmaceutical equipment.
The materials exceptional thermal stability allows it to operate across a wide temperature range, typically from -50°C to 180°C or higher, without degrading. This makes it suitable for applications involving sterilisation processes, high-temperature cooking or freezing conditions. Additionally, FDA approved silicone rubber resists microbial growth, which is essential for maintaining hygiene in food and healthcare settings.
Chemical resistance is another advantage of this material. It withstands exposure to oils, solvents and cleaning agents which aids durability in demanding environments. Furthermore, its flexibility and resilience make it ideal for dynamic applications, such as rubber seals, tubing and gaskets that experience repeated movement or pressure changes. Finally, its compliance with FDA regulations provides peace of mind to manufacturers and end-users, ensuring products meet the highest safety standards.

Common Applications and Uses
This compounds unique properties make it a useful material in a range of industries. Below are three key application areas:
Industries

Food and Beverage
In the food and beverage sector, this material is employed in applications such as silicone seals, gaskets and tubing for food processing equipment. Its ability to resist high temperatures makes it suitable for use in baking mats, moulds and cookware, while its non-toxic properties ensure food safety. FDA approved silicone is also used in beverage dispensing systems, where its chemical resistance and flexibility ensure reliable performance without contamination risks.

Medical, Pharmaceutical & Healthcare
In the healthcare industry, FDA approved silicone rubber is widely used for medical devices and equipment that require sterilisation or contact with bodily fluids. Examples include tubing, catheters, seals and implantable devices. Its biocompatibility ensures it does not cause adverse reactions, while its thermal stability allows it to endure autoclaving and other sterilization processes. The materials flexibility and resilience make it ideal for disposable and reusable medical products.

Aerospace
In the aerospace industry, FDA approved silicone rubber is used for seals, gaskets and insulation in aircraft systems that require materials to meet stringent safety and performance standards. Its ability to resist extreme temperatures and maintain its properties in high-altitude, low-pressure environments makes it ideal for cabin pressurisation systems and thermal insulation. Additionally, its chemical resistance ensures durability in contact with aviation fuels and hydraulic fluids.
Material Compound Datasheets
As FDA approved silicone is based on a general purpose compound, it can be extruded in a range of different hardnesses. The properties and characteristics of these hardnesses may differ. Please see the downloadable PDF material compound datasheets for this information.
Looking for a different grade of Silicone?
As well as FDA approved silicone, we are also able to manufacture rubber sealing products in a selection of other specialised Silicone compounds. This includes general purpose silicone, metal detectable silicone, high temperature silicone and flame retardant silicone.
Contact Us
With over 50 years' experience in the rubber sealing industry, our team has extensive experience in finding sealing solutions for our customers. Contact our experts via phone or email for sealing advice or bespoke quotations.
Email:
sales@sealsplusdirect.co.uk
Telephone:
01425 617722