Materials of Excellence

Crafting with the Best in the Business

At Julong Rubber, we prioritize using the finest materials to ensure the durability, efficiency, and performance of every product. Explore the various high-quality materials that form the foundation of our premium rubber components.

Food and Drug Administration (FDA) Approved Rubber

Ensuring Safety in Food and Pharmaceutical Contact

FDA-approved elastomers are those that meet the stringent standards set by the FDA for applications where the rubber will come into direct contact with food or drugs. These elastomers are free from harmful chemicals or additives that might leach into the product they’re in contact with, ensuring the safety and purity of food and medicines.

Food and Drug Administration (FDA) Approved Rubber

FDA-approved elastomers are vital for industries that require strict health and safety compliance. These rubbers are formulated to meet the FDA’s regulations for direct contact with food, beverages, pharmaceuticals, and drinking water. In this comprehensive guide, I’ll explain what makes a rubber FDA-compliant, explore different FDA-approved materials, and offer B2B procurement advice for selecting the right FDA rubber for your application.

What is FDA Approved Rubber?

FDA-approved rubber refers to elastomers that comply with the FDA’s Code of Federal Regulations (CFR) Title 21, which defines materials safe for direct contact with food, drugs, and potable water. These rubbers are free from toxic substances, plasticizers, or dyes that can leach into consumable products. They are tested for purity, non-toxicity, and resistance to contamination.

FDA rubber ensures safe and hygienic sealing in industries like food processing, beverage, pharmaceutical, and medical equipment manufacturing.

Types of FDA Rubber

Several rubber materials are formulated to comply with FDA standards. Each type has specific benefits depending on its chemical composition and intended application.

Rubber Type	Temperature Range	Key Properties	Typical Applications
FDA Silicone Rubber (VMQ)	-60°C to +230°C	Inert, non-toxic, excellent temperature resistance	Food processing, medical devices, baby products
FDA EPDM Rubber	-50°C to +150°C	Excellent resistance to water, steam, and cleaning agents	Dairy equipment, drinking water systems, clean rooms
FDA Nitrile Rubber (NBR)	-30°C to +120°C	Good oil and grease resistance, economical	Food-grade seals, gaskets, beverage dispensers
FDA Fluorocarbon (FKM)	-26°C to +205°C	Chemical resistance, high-temperature stability	Pharmaceutical sealing, aggressive cleaning chemicals

What are the Advantages and Disadvantages of FDA Rubber?

✔️ Advantages

✅ Safe for direct contact with consumables (food, water, pharmaceuticals)
✅ Non-toxic and free from harmful substances
✅ Excellent resistance to aging, ozone, and UV in sanitary environments
✅ Compliance with international food safety standards (FDA, EC 1935/2004)

❌ Disadvantages

❌ Limited chemical resistance in some materials (e.g., EPDM vs. oils)
❌ Generally more expensive due to compliance requirements
❌ Limited color options—typically white, translucent, or blue for detection

🔧 Advantages vs Disadvantages Table

Feature	Advantages	Disadvantages
Safety Compliance	FDA approved, non-toxic, hygienic	Certification adds cost
Chemical Resistance	Excellent with certain elastomers (FKM, Silicone)	Limited with EPDM (oils) and NBR (chemicals)
Temperature Range	Wide (up to 230°C for Silicone)	Material dependent

What is FDA Rubber Used For?

FDA rubber is extensively used in industries where hygiene, safety, and compliance are mandatory.

🍽️ Food & Beverage Industry

✅ Seals and gaskets in food processing equipment
✅ Conveyor belts, piping seals, beverage dispensing valves
✅ Dairy seals and O-rings in milk processing

🏥 Pharmaceutical & Medical Industry

✅ Medical device seals and gaskets
✅ Pharmaceutical packaging, IV drip connectors
✅ Sanitary seals in clean room environments

🚰 Drinking Water Systems

✅ Potable water system seals (FDA + NSF compliance)
✅ Water filtration system gaskets and seals

🔧 Industry Applications Performance Table

Industry	Temperature Range	Sanitation Standards	Durability
Food & Beverage	-30°C to +150°C	FDA CFR 21, EC 1935/2004	High
Pharmaceutical & Medical	-60°C to +230°C	FDA, USP Class VI	Very High
Drinking Water Systems	-50°C to +150°C	FDA, NSF/ANSI 61	High

What is the Difference Between Food Grade Rubber and Medical Grade Rubber?

✅ Food Grade Rubber: Meets FDA requirements for contact with food and beverages. Prioritizes resistance to oils, fats, and cleaning agents. Common in processing and packaging equipment.
✅ Medical Grade Rubber: Complies with stricter regulations (FDA + USP Class VI). Requires biocompatibility, sterilization resistance, and ultra-pure formulations suitable for implantation or direct human contact.

🔧 Food Grade vs Medical Grade Rubber Table

Feature	Food Grade Rubber	Medical Grade Rubber
Regulatory Standards	FDA CFR 21, EC 1935/2004	FDA, USP Class VI, ISO 10993
Biocompatibility	Not mandatory	Required
Sterilization Resistance	Optional	Mandatory (Autoclave, Gamma)
Applications	Food processing, packaging	Implants, IV connectors, surgical tools

How to Choose FDA Rubber?

🔍 Step 1: Define Application Requirements

✅ Contact material (food, water, pharmaceuticals)
✅ Operating temperature range
✅ Exposure to oils, cleaning chemicals, sterilization processes

🔍 Step 2: Select the Right Rubber Material

Rubber Type	Temperature Range	Key Benefits	Applications
Silicone (VMQ)	-60°C to +230°C	Biocompatible, sterilizable	Medical, food processing, beverage
EPDM	-50°C to +150°C	Steam, water resistance	Dairy, drinking water systems
NBR	-30°C to +120°C	Oil, fat resistance	Food-grade seals, dispensers
FKM (Viton)	-26°C to +205°C	Chemical resistance	Pharma, aggressive cleaning agents

🔍 Step 3: Verify Compliance and Certifications

✅ FDA CFR 21 Compliance
✅ USP Class VI (for medical applications)
✅ NSF/ANSI 61 (drinking water components)

📞 Get a Free Quote or Sample of FDA Rubber Components!

At Julong Rubber, we offer FDA-approved elastomers for food, beverage, pharmaceutical, and medical applications. Our B2B solutions include custom rubber molding, extrusion, and full compliance with regulatory standards.