FDA Silicone Rubber is a specialist silicone rubber material approved by the U.S. Food and Drug Administration (FDA) for various applications. This approval signifies that the silicone elastomer meets the stringent safety and quality standards set by the FDA, making it suitable for applications where direct or indirect contact with food, beverages, pharmaceuticals, or other consumables is possible. 

The importance of FDA approval in silicone rubber products must be considered. It assures manufacturers, suppliers, and end-users that the material is safe, non-toxic, and suitable for its intended purpose. Without FDA approval, there is a risk of contamination which can have serious health implications or legal consequences. 

At Delta Rubber Limited we offer a range of FDA-approved silicone rubber materials, specifically formulated and manufactured to meet the standards set by the FDA for the utmost safety and quality. Offering all the benefits of traditional silicone rubber – such as flexibility, durability, and heat resistance – while also ensuring compliance with FDA regulations for food contact materials. 

FDA Regulations for Silicone Rubber 

The U.S. Food and Drug Administration (FDA) regulates silicone rubber materials to ensure their safety and suitability for various applications, particularly those that come into contact with consumables. Understanding these regulations is crucial for manufacturers and end users alike to maintain compliance and uphold standards of quality and safety – but how is a product FDA-approved?

Criteria for FDA Approval

For silicone rubber to receive FDA approval, it must undergo rigorous testing and evaluation to demonstrate its compliance with regulatory standards. This includes assessments of the materials composition, manufacturing processes, and potential migration of substances that could pose health risks. Products that meet these criteria are granted FDA approval and deemed safe for their intended use. 

Importance of FDA Approval for Manufacturers & End-Users 

Compliance with FDA regulations is paramount for both manufacturers and end-users of silicone rubber products. For manufacturers, adherence to FDA guidelines is not only a legal requirement but also a moral obligation to prioritise consumer safety. Failure to comply can result in costly recalls, legal ramifications and damage to reputation. 

For end-users, choosing FDA-approved silicone rubber products ensures peace of mind knowing that they meet the highest standards of safety and quality. Whether it’s food processing equipment, medical devices, or household items, opting for FDA-approved silicone rubber minimises the risk of contamination and potential harm to consumers. 

Why Use FDA-Approved Silicone Rubber?

FDA-approved silicone rubber offers numerous advantages over non-compliant alternatives, making it the preferred choice for applications where safety and quality are paramount. Here are several compelling reasons to opt for FDA-approved silicone rubber: 

Safety Assurance – FDA approval ensures silicone rubber products have undergone rigorous testing to verify their safety for use in contact with food, beverages, pharmaceuticals, and other consumables.

Regulatory Compliance – Using FDA-approved silicone rubber demonstrates compliance with industry standards and regulatory requirements, providing confidence to manufacturers, suppliers and end-users. 

Quality & Purity – Products that meet FDA standards are free from harmful substances, additives, and impurities that could compromise product integrity or consumer safety. 

Versatility and Performance – FDA-approved silicone rubber offers the same versatility, flexibility, and durability as non-compliant alternatives, making it suitable for a wide range of applications. 

In summary, the use of FDA-approved silicone rubber is essential for ensuring safety, regulatory compliance and quality in various industries. By prioritising using FDA-approved materials, businesses can mitigate risks, uphold standards of safety and instil confidence in their processes. 

Applications of FDA-Approved Silicone Rubber 

FDA-approved silicone rubber finds widespread use across various industries due to its safety, durability, and regulatory compliance. In this section, we’ll explore the diverse applications of FDA-approved silicone rubber and its significance in maintaining safety, quality and performance standards in different sectors. 

Food Processing

In the food processing industry, FDA-approved silicone rubber is indispensable for maintaining food safety and quality. It is widely used in equipment components like seals, gaskets and O-rings due to its ability to withstand extreme temperatures and resist chemicals. 

Medical & Healthcare

Highly valued in healthcare, FDA-approved silicone rubber’s biocompatibility and sterilisation capabilities make it ideal for medical devices. Used in tubing, catheters, seals, and implants, its inert nature reduces the risk of adverse reactions, making it efficient and safe for pharmaceutical products. 


In the pharmaceutical industry, FDA-approved silicone rubber plays a vital role in packaging and sealing medication. Its properties maintain the purity and stability of pharmaceuticals, protecting them from contamination and degradation. 

Beverage and Bottling 

The go-to material for beverage and bottling processes, FDA-approved silicone rubber provides reliable sealing and protection against leakage and contamination. Seals, gaskets, and closures made from FDA-approved silicone ensure beverage packaging integrity, preserving drink freshness and quality.

Consumer Products 

In consumer products, FDA-approved silicone rubber finds widespread application in household items and personal care products. Non-toxic, flexible, and heat resistant, it’s ideal for manufacturing silicone moulds, utensils, baby products and hygiene items. From kitchenware to personal care accessories, it enhances product safety and durability. 

Types of FDA Approved Silicone Rubber Materials 

White FDA Approved Silicone Rubber 

White FDA approved silicone rubber is a versatile and cost-effective material for industries where adherences to FDA regulations is imperative. Manufactured to meet the stringent FDA standards, our white silicone rubber variant ensures safety and purity in applications involving contact with food, beverages, and pharmaceuticals. 

The white colouration of the materials not only provides clarity but also underscores its suitability for environments where cleanliness and hygiene are paramount. Commonly used in food processing equipment seals and medical device components, white FDA approved silicone rubber offers reliability and peace of mind, meeting the highest standards of regulatory compliance. 

  • Temperature Range: -60°C to +230°C
  • Hardness: 60°±5 Shore A
  • Tensile Strength: 7.9 Mpa
  • Elongation at break: 340%

Metal Detectable Silicone Rubber 

Metal detectable silicone rubber is a highly unique FDA approved material engineered for industries where product contamination must be minimised, particularly in food processing and packaging. The silicone rubber variant contains metal particles that enable detection by metal detectors and x-ray inspection systems, ensuring swift identification and removal of contaminated products. 

Metal detectable silicone rubber is widely used in the food processing, packaging, beverage and pharmaceutical industries for conveyor belts, gaskets and packing areas, offering an extra layer of safety and compliance with FDA regulations. Its ability to enhance product traceability and mitigate the risk of foreign objectives underscores its importance in maintaining safety and consumer confidence. 

  • Temperature Range: -60°C to +200°C
  • Hardness: 60°±5 Shore A
  • Tensile Strength: 7.0 N/mm2
  • Elongation at break: 400%

Where to Buy FDA Approved Silicone Rubber Online 

At Delta Rubber Limited, we are trusted suppliers of FDA approved silicone rubber to industries including healthcare, food processing, pharmaceuticals and more. We offer both White FDA Approved Silicone Rubber and Metal Detectable FDA Approved Silicone Rubber, available to buy online through our easy-to-use online shop. Take advantage of our range of thicknesses, widths and length options to find the perfect solution for your needs. 

Additionally, we offer bespoke FDA approved silicone rubber components manufactured upon request including gaskets, washers, seals and more. Our in-house manufacturing machinery ensures precision and accuracy in production, guaranteeing high-quality, tailor-made solutions for our customers. 

There are other FDA approved silicone rubber materials available, and these can be sourced upon request. Please don’t hesitate to contact a member of our sales team for assistance in sourcing your desired material. Leveraging our buying power, we are able to provide cost-savings directly to you, ensuring that you receive the best value for your investment in FDA approved silicone rubber materials.