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Last updated: February 2026
This directory lists 57 medical grade silicone manufacturers across the United States, from advanced Liquid Silicone Rubber (LSR) injection molders specializing in micro-molding to High Consistency Rubber (HCR) extruders producing tubing and profiles.
Buyers in this space are solving critical problems related to material biocompatibility, long-term implantability, fluid resistance, and sterilizability. The right manufacturer ensures components meet stringent requirements like USP Class VI for contact with body fluids, or specific ISO 10993 protocols for cytotoxicity, sensitization, and irritation, preventing costly redesigns or regulatory roadblocks down the line.
Suppliers in this category vary significantly. Some focus exclusively on high-volume, automated production of standard LSR components, while others specialize in custom, complex HCR gaskets or intricate implantable devices requiring extensive secondary operations and specialized post-cure processes. Distinctions also arise in their cleanroom capabilities, ranging from ISO Class 8 for general medical components to ISO Class 7 or even Class 6 for more critical or implantable parts.
To engage effectively, buyers should prepare detailed product specifications, including durometer, tensile strength, elongation, and tear strength, along with a clear understanding of the regulatory pathway (e.g., FDA Class I, II, or III) and intended use. Suppliers will expect CAD files, material certifications, and any specific requirements for validation, process qualification (IQ/OQ/PQ), and packaging in a controlled environment.
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57 companies nationwide
Based in Cherry Hill, NJ, American Rubber Products specializes in advanced silicone manufacturing, offering medical-grade silicone sheeting, sponge, and custom solutions. The company provides solid silicone, uncured silicone compounds, molded parts, and engineered rubber products for critical applications, leveraging state-of-the-art capabilities for precision components.
Based in Santa Ana, CA, ASP Seal is a U.S. supplier of medical-grade silicone solutions. They specialize in manufacturing high tear silicone gaskets and providing silicone gasket material for healthcare and various industrial applications, ensuring durable products for critical needs.
Based in Leominster, MA, Beacon MedTech specializes in the manufacture of precision molded thermoplastic, thermoset, and silicone parts. They utilize processes such as injection, liquid injection (LIM), compression, and transfer molding, providing components tailored for the medical technology sector.
Based in Santa Barbara, CA, Bentec Medical specializes in custom medical-grade silicone fabrication for device OEMs. The company designs and manufactures implant-grade components, offering extensive services including design consultation, prototyping, regulatory support, assembly, sterilization, and packaging.
Based in Sanford, ME, Casco Bay Molding is an ISO 13485:2016 certified product development and injection molding facility. They specialize in high-volume silicone and thermoplastic production, focusing on Class I and II medical device components. Services include in-house tooling, design, mold making, and production.
Based in Lake Villa, IL, CS Hyde Company specializes in custom conversion services including die cutting, laminating, slitting, and sheeting of materials. They provide medical grade silicone rubber sheets that are translucent, USP Class VI compliant, low volatile, peroxide-free, and platinum cured for various industrial applications.
Based in Berkeley, CA, Custom Rubber Silicone Molds is a significant manufacturer specializing in medical-grade silicone molding. The company produces high-quality medical silicone products, catering to industries requiring precision and adherence to strict standards for medical applications.
DWK Life Sciences manufactures platinum-cured, translucent silicone tubing specifically designed for medical, laboratory, and pharmaceutical applications. Their high-quality tubing meets USP Class VI standards, ensuring optimal purity and performance for reliable and safe fluid transfer in critical environments.
Based in Santa Fe Springs, CA, ElastaPro Silicone Sheeting manufactures medical-grade silicones, offering sheets, rolls, and compounds. Their biocompatible and hypoallergenic materials are ideal for healthcare applications, including medical devices, pharmaceuticals, and consumer health goods. These silicones resist cleaning chemicals and extreme temperatures.
Elastostar Rubber Corporation manufactures custom extruded and molded silicone rubber products, supplying FDA-approved and medical-grade materials for medical and biotech use. Based in Plain City, OH, the company is ISO 9001:2015, AS9100D, and IATF 16949 certified, serving industries including medical equipment.
Elastomer Technologies, Inc. specializes in custom molding and die-cutting elastomer parts, including injection, transfer, compression, and liquid injection molding. They provide high-quality engineered solutions and prototypes, with extensive experience serving the medical and dental sectors.
Gulf Rubber manufactures custom engineered liquid silicone rubber components. Specializing in material science, engineering, and design, they provide compounding, molding, and rapid prototyping services for diverse industries. The company develops vital medical device components, performing rigorous testing in-house to ensure high-quality, durable sealing solutions.
Based in Granger, IN, Gumena LLC specializes in silicone manufacturing and custom compounding. They provide high-consistency silicone compounds and silicone putty, mixed according to customer specifications. Serving the medical, industrial, and consumer markets, Gumena operates under ISO 9001:2015 quality standards for reliable material solutions.
HDA Technology Inc. provides comprehensive medical device contract manufacturing services, covering product design, rapid prototyping, tooling, and precision injection molding. They specialize in both plastic and liquid silicone rubber (LSR) injection molding, cleanroom assembly, and packaging for medical devices.
Based in Placentia, CA, Handy Service Corporation manufactures silicone gaskets and seals for the medical and food packaging industries. They specialize in custom-designed aluminum molds and gaskets, offering products like T-strips, flat-sheet gaskets, and heat sealer bars. The company serves clients throughout the United States and internationally.
Based in Tustin, CA, Ingenarious Consultants offers precision contract manufacturing for medical device innovation. Specializing in early-stage development, they guide products from concept to manufacturing, providing services like silicone molding, 3D printing, and machining for component production and low-volume builds.
InterSil, based in Santa Fe Springs, CA, manufactures custom silicone compounds and products. They engineer high-purity silicone solutions, including sheets, fluorosilicone, and high-temp options, meeting medical-grade, food-grade, and military-grade standards for diverse industries. All manufacturing occurs in the USA.
Based in Gloucester, MA, Interstate Specialty Products specializes in custom fabrication of high-performance materials for diverse industries. They offer precision die-cutting, waterjet cutting, and molding services for FDA-grade and USP Class VI silicones, producing gaskets, seals, tubing, and custom parts for medical devices.
IRP Medical, based in San Clemente, CA, specializes in molding critical-to-function elastomeric components and silicone extrusions for the medical device industry. Offering LSR and LIM processes, the company holds ISO 13485 certification and FDA registration, providing scalable manufacturing from prototype to high-volume production.
Molded Rubber and Plastics Corporation is a US-based manufacturer specializing in custom molded rubber and silicone components. They provide precision parts for commercial, industrial, and medical applications, ensuring quality through established assurance processes. The company focuses on delivering high-performance components tailored to specific client needs.
NewAge Industries, based in Southampton, PA, manufactures SILCON MEDICAL tubing that meets USP Class VI requirements. This medical-grade silicone tubing features low surface energy to resist adhesion and inhibit bacteria growth, providing specialized solutions for medical applications with high-quality and compliance.
Newman Sanitary Gasket manufactures USP Class VI and FDA compliant medical-grade silicone products. They produce sanitary gaskets, O-rings, diaphragms, and custom seals for high purity process industries, including pharmaceutical applications. The company provides custom molding, extrusions, and sheet materials from compounds formulated for rigorous sanitary standards.
Based in Crown Point, IN, Point Medical Corporation specializes in custom development and fabrication of implant-grade silicone rubber devices and assemblies for the medical environment. They operate an FDA-registered, ISO13485:2016 certified facility with a Class 10,000 Clean Room, offering in-house prototype development and tooling.
Based in Burbank, CA, ProcessHQ provides engineered solutions and critical process components for biotech companies. They specialize in manufacturing products from USP Class VI, platinum-cured silicone elastomer. The company develops custom solutions, delivering them on-time for both upstream and downstream biotechnology applications.
Based in Plymouth, MN, ProMed Molded manufactures complex, medical-grade silicone and plastic components. They produce over-molded silicone and thermoplastic assemblies for long and short-term implantable and disposable medical devices, plus pharmaceutical dosage forms. Services span prototype to production for regulated industries.
QMD specializes in manufacturing medical-grade silicone and elastomeric components and devices for OEMs. Services include precision component fabrication, custom subassemblies, device assembly, packaging, and sterilization in ISO-certified facilities. Leveraging decades of expertise, QMD offers end-to-end solutions backed by comprehensive regulatory approvals.
Based in Santa Fe Springs, CA, RD Rubber Technology Corp. specializes in custom rubber and liquid silicone molding. The company offers cleanroom molding and silicone to plastic bonding capabilities, manufacturing precision components for diverse applications, including critical parts for medical device equipment.
Rubber Molded Products specializes in various types of medical silicone molding for critical applications. The company provides custom silicone components designed for use in both industrial and medical environments. They focus on manufacturing precise parts that meet stringent industry standards for performance and biocompatibility.
San Diego Seal, Inc. based in San Diego, CA, provides medical grade silicone (USP Class 6) and extreme high tear silicone. The company serves diverse industries including energy production, water districts, wastewater treatment, manufacturing, and transportation systems.
SILIKON Technologies provides precision silicone injection molding services with a Quality Management System registered to ISO 13485 and ISO 9001. They serve various medical and life science industries, including device, pharmaceutical, and dental, offering Class 7 and 8 clean room environments.
Based in Miramar, FL, Simtec Silicone specializes in high-quality liquid silicone rubber (LSR) and multi-shot molded components. They provide custom solutions for medical, healthcare, mobility, and industrial industries, from concept through high-volume production. The company utilizes advanced LSR injection molding and an ISO-certified class 8 clean room, holding ISO 13485 certification.
Based in Saginaw, MI, SMI Manufacturing is a contract manufacturer specializing in custom-engineered silicone products since 1979. The company provides medical grade silicone solutions for implantable applications and clean-room environments, offering services such as injection molding, compression molding, and component assembly for various industries.
Techlink Silicone, an American manufacturer in Niles, MI, specializes in medical-grade silicone solutions. They offer custom compounding, injection molding, and extrusion for precision components. ISO 13485 certified, Techlink provides high-quality, biocompatible silicone parts for medical device manufacturers, utilizing cleanroom environments.
Based in Midvale, UT, Utah Medical Products, Inc. provides advanced silicone and thermoplastic molding capabilities for both medical and non-medical applications. The company manufactures various medical devices, including cervical ripening catheters, suprapubic catheters, enteral feeding systems, and uterine balloon tamponade catheters for healthcare providers.
Based in Danbury, CT, Vanguard Products Corporation is a full-service manufacturing and engineering company specializing in high-precision elastomeric fabricated goods. With over fifty years of experience, they design and manufacture medical-grade silicone tubing, extrusions, and custom molded rubber products, serving various industries.
DuPont, through its Liveo brand, manufactures a comprehensive portfolio of silicone elastomers. These include high-consistency rubbers (HCRs), liquid silicone rubbers (LSRs), and soft filling elastomers. These materials are crucial components for the production of various industrial and medical-grade silicone applications.
RJC Mold, located in Lake Forest, CA, specializes in liquid silicone rubber injection molding for medical contracts, utilizing ISO Class 8 cleanrooms and meeting FDA requirements. They also offer plastic injection molding, overmolding, and two-shot molding services, providing comprehensive manufacturing solutions from prototyping to production.
Silicone Polymers manufactures medical implant grade silicones, including liquid silicone rubbers. They provide detailed product specifications, such as durometer, tensile strength, and stress values, to meet the stringent requirements of biomaterials applications.
Ace Sanitary manufactures sanitary and high-purity liquid transfer solutions, including bulk USP Class VI silicone tubing. They provide single-use assemblies, sanitary process hoses, and pharma gaskets, designed for critical medical, biopharma, and laboratory fluid transfer applications. Their products focus on non-toxic, high-purity materials for demanding environments.
Axiom Medical, an ISO 13485 and FDA-registered manufacturer in Torrance, CA, specializes in medical-grade silicone extrusions. They were the first medical manufacturer to introduce full silicone wound drains in the USA. The company provides high-quality silicone products for medical and commercial applications, all made entirely in the USA.
Based in Greeneville, TN, Specialty Silicone Fabricators specializes in producing custom silicone-based products. They serve diverse applications, including medical devices, industrial equipment, and consumer products, providing comprehensive silicone manufacturing solutions for various industries.
Based in New Carlisle, OH, California Medical Innovations specializes in dip molding processes for medical applications. The company manufactures a wide range of medical-grade silicone products, including precision tubing, catheter balloons, and various seals, serving the medical device industry with custom components.
Based in Northfield, NH, Eptam manufactures thermoplastic and silicone components. Operating ISO Class 8 clean rooms, they provide injection molding, design for manufacturing, and scalable production for complex engineering. Eptam serves industries with critical applications where high-quality parts 'touch lives'.
Extreme Molding is a US-based silicone injection molder specializing in high-performance silicone products for diverse markets. They offer full-service production for medical components, healthcare products (including those for women and infants), and life science applications, encompassing molding, assembly, packaging, and fulfillment.
HPS Performance Products manufactures custom silicone hoses, couplers, and tubing. They provide medical grade, high temperature platinum cured silicone hose and tubing, meeting USP Class VI requirements. The company serves diverse sectors, from high-performance racing and marine to food and beverage and general manufacturing.
Master Bond formulates and manufactures high-performance adhesives, sealants, and coatings in their USA facility. They specialize in medical grade silicone systems, designed to meet USP Class VI and ISO 10993-5 biocompatibility requirements for medical device assembly. Products are made-to-order for specific application needs.
Based in Plymouth, MN, Minnesota Rubber & Plastics provides custom LSR (Liquid Silicone Rubber) design, prototyping, and manufacturing services. The company specializes in complex molded components and seals for medical devices and other demanding industries, utilizing advanced materials science and global manufacturing capabilities.
M.R. Mold & Engineering, based in Brea, CA, specializes in the design and manufacture of liquid silicone rubber (LSR) and gum stock silicone products. The company offers plastic injection, micro, overmolding, and insert molding services, focusing on complex geometries. They operate a Molding Tech Center to produce custom plastic and silicone parts.
Based in Lugoff, SC, Surgiform Innovative Surgical Products manufactures and distributes medical-grade silicone facial implants and carvable blocks. Their FDA-registered facility, Surgical Technology Laboratories, Inc. produces high-quality, sterile implantable silicone products for aesthetic and plastic surgery, backed by over 20 years of clinical history.
Cirtec Medical designs, develops, and manufactures medical devices, emphasizing expertise in silicone and elastomers. They provide precision engineering, biocompatible materials, and advanced processing solutions. The company focuses on accelerating design, reducing costs, and expediting time to market for innovative medical devices.
Based in Midland, MI, Dow manufactures high-performance medical-grade silicone materials, including SILASTIC™ liquid silicone rubbers (LSR). These advanced silicones provide durable, biocompatible solutions essential for critical healthcare applications. Dow supplies medical device manufacturers with materials for diverse components throughout the United States.
Based in Chicago, IL, Flexan, LLC specializes in custom rubber and plastic molding, providing precision medical-grade silicone components. The company offers ISO 13485 certified silicone molding services primarily for medical device manufacturers. They deliver high-quality, custom-molded parts, along with engineering and assembly solutions.
Freudenberg Medical specializes in silicone molding and extrusion, producing implant, medical, and pharma-grade silicones compliant with USP Class VI standards. As a CDMO partner, they support medical device and pharmaceutical innovation from design to full-scale production, leveraging deep materials expertise.
Based in Anaheim, CA, Konark Silicones is a US manufacturer specializing in complex silicone part design and molding. They produce high-quality parts using medical grade silicone rubber, liquid silicone rubber (LSR), and high consistency rubber (HCR). Services include silicone injection and compression molding, along with prototyping for industrial customers.
Lubrizol provides contract manufacturing services utilizing silicones for the medical industry. The company also supplies renowned medical-grade thermoplastic polyurethane materials, supporting various applications within the healthcare sector.
NuSil develops and manufactures implant-grade silicones for biostable medical implants. They offer a range of ultra-pure elastomers, low outgassing coatings, and reliable adhesives, specifically engineered to meet the stringent requirements of the medical device industry for implantable applications.
Shin-Etsu Silicone is a global manufacturer specializing in high-performance silicone materials. They produce a vast array of silicone products, including dedicated medical-grade silicones for healthcare, medical device, and pharmaceutical applications. With US headquarters in Houston, Texas, and manufacturing facilities in Ohio, the company directly supplies B2B customers.
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Medical grade typically refers to silicones that meet USP Class VI standards for biocompatibility and are suitable for limited body contact. Implantable grade, however, demands an even higher level of purity and rigorous testing, often involving specific ISO 10993 protocols for long-term biocompatibility, extractables, and sometimes mechanical stability for devices intended for permanent or extended internal use. The supplier's documentation and cleanroom class for manufacturing will reflect this distinction.
A post-cure is crucial for many medical silicone components, especially those intended for long-term implant or drug delivery applications. It's a heat treatment that significantly reduces volatile organic compounds (VOCs) and enhances the material's mechanical properties, leading to improved biocompatibility and stability. If your device involves fluid contact, extended internal exposure, or tight extractables limits, a validated post-cure is almost certainly required for regulatory compliance and patient safety.
The required cleanroom class depends entirely on your device's risk profile and intended use. For non-critical, external components, an ISO Class 8 (Class 100,000) might suffice. However, for internal body contact, sterile applications, or implantable devices, you'll need at least an ISO Class 7 (Class 10,000) or even ISO Class 6 (Class 1,000) environment to minimize particulate contamination and ensure product integrity. Always specify your target cleanroom class early in discussions.
Request detailed material certifications from the supplier, including a Certificate of Analysis (CoA) and a Certificate of Conformance (CoC), explicitly stating USP Class VI compliance and, if applicable, ISO 10993 test results. Verify that the material is platinum-cured, as peroxide-cured silicones are generally not suitable for medical applications due to potential residual byproducts. A reputable supplier will have robust traceability from the raw material manufacturer.
For medical devices, tooling is a critical asset. Ensure your contract clearly stipulates your ownership of the mold/tooling and specifies the manufacturer's responsibilities for preventative maintenance, repair, and secure, controlled storage. A supplier who is reluctant to discuss these terms, or who claims ownership of tooling you paid for, presents a significant risk to your intellectual property, production continuity, and regulatory compliance.
For any medical device, process validation (Installation Qualification, Operational Qualification, Performance Qualification) is a fundamental regulatory requirement, especially for Class II and Class III devices. While it might not be explicitly "offered" in a standard quote, it should be an expected capability for any ISO 13485 compliant manufacturer. You absolutely must explicitly discuss and define the scope of IQ/OQ/PQ for your project with the supplier, as it directly impacts product quality, consistency, and regulatory approval.