Medical Grade Silicone
Medical grade silicones from ElastaPro are used for sealing and gasketing in medical devices and equipment. These platinum-cured materials meet FDA Title 21 CFR 177.2600, USP Class VI, ISO 10993, and European Pharmacopoeia requirements. ElastaPro manufactures medical silicones in the United States and supplies them as solid sheets, continuous rolls, and uncured compounds.
Although ElastaPro doesn’t supply major medical OEMs directly, our materials are known and trusted by leading manufacturers of medical devices and equipment. The fabricators that we partner with have presented us as their supplier of medical grade silicones, and ElastaPro has passed audits by major medical OEMs with names that you’d recognize.
Keep reading to learn more and contact ElastaPro for a quote.
What are Medical Grade Silicones?
Medical grade silicones are formulated for a higher degree of purity than general purpose grade silicones. That’s because medical silicones directly contact – and must not have a negative effect upon – human skin, blood and fluids, or living tissue. The medical elastomers that ElastaPro makes aren’t designed for long-term implantation, but they’re free from substances that could cause harmful biological reactions during short-term use (<29 days in the body).
ElastaPro’s medical grade silicones are biocompatible, hypoallergenic, and do not have an unpleasant smell or odor. They also resist cleaning chemicals, bodily fluids, and bacterial growth. These medical elastomers are safe for steam and gamma sterilization, do not contain organic plasticizers, and are phthalate and peroxide free. Importantly, they comply with FDA Title 21 CFR 177.2600, USP Class VI, ISO 10993, and European Pharmacopeia monograph 3.19.
Specifications Grade Materials
Medical grade silicones from ElastaPro are specifications grade materials that meet the following regulations and standards.
- FDA Title 21 CFR 177.2600 is a regulation that establishes low levels of extractables, substances that can leach from a material. Although this U.S. regulation does not explicitly govern medical devices, it’s a preferred starting point among medical manufacturers.
- USP Class VI is a biocompatibility standard from the United States Pharmacopeia (USP), a non-profit organization. The FDA recognizes and uses this standard, which establishes testing protocols and complements the FDA’s own 21 CFR 177.2600.
- ISO 10993 is an international standard for evaluating the biocompatibility of medical grade silicones. It contains more extensive testing requirements than USP Class VI and ensures that medical devices don’t cause adverse biological reactions in the people who use them.
- European Pharmacopoeia standards ensure that a material is safe for pharmaceutical use. It includes requirements for both biocompatibility and chemical properties. Ph. Eur monograph 3.19 applies to silicone elastomers for closures (containers) and tubing.
The table below compares these standards.
| Standard | What It Covers | Primary Purpose | Testing Requirements | Typical Use Cases | How It Relates to Silicone |
| USP Class VI | Biocompatibility testing for materials used in medical and pharmaceutical applications | Ensures materials do not cause toxicity, irritation, or adverse biological reactions | Systemic toxicity test
Intracutaneous reactivity test Implantation test (short‑term) Extracts tested in saline & vegetable oil |
Medical device components, tubing, gaskets, seals, pharmaceutical contact parts | Platinum‑cured silicone typically passes due to low extractables, chemical inertness, and high purity |
| ISO 10993 | Comprehensive international framework for evaluating medical device biocompatibility | Determines biological safety of finished medical devices based on type and duration of body contact | Modular testing: cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, and more | Full medical device approval, long‑term implants, regulatory submissions | Silicone often used in devices requiring ISO 10993 compliance; platinum‑cured grades align well with long‑term biocompatibility needs |
| FDA 21 CFR 177.2600 | U.S. FDA regulation for rubber articles intended for repeated food contact | Ensures materials do not leach harmful substances into food | Chemical extractables limits in water & n‑hexane; strict formulation requirements | Food‑grade seals, gaskets, processing equipment, beverage systems | Many silicone formulations meet both FDA 177.2600 and USP Class VI, making them suitable for dual food‑contact and medical‑adjacent applications |
| Ph. Eur. 3.1.9 (European Pharmacopoeia) | Requirements for silicone elastomers used in pharmaceutical and medical applications | Ensures materials used in contact with medicinal products meet purity and safety criteria | Identity tests
Extractables limits Volatile content Cross‑linking verification Transparency & physical property checks |
Pharmaceutical processing equipment, medical device components, drug‑contact parts | Platinum‑cured silicone typically meets Ph. Eur. 3.1.9 due to low extractables, stable chemistry, and consistent curing |
Certificates of Analysis (COAs)
ElastaPro’s medical grade silicones meet all these requirements, and we offer a full Certificate of Analysis (COA) with every batch. Unlike a Certificate of Conformance (COC), a COA does not simply attest that a material meets requirements. Instead, a COA contains batch-level test data. Medical grade silicones from ElastaPro are typically translucent, but buyers can request materials that are white, red, blue, green, gray, or available in custom silicone colors.
Medical Grade Silicone Sheets
Medical grade silicone sheets are high‑purity elastomeric materials engineered for demanding healthcare, pharmaceutical, and life‑science applications. Because they are typically formulated with platinum‑cured silicone, these sheets offer exceptional cleanliness, low extractables, and consistent biocompatibility—key attributes for devices that contact skin, tissue, or medical fluids. Manufacturers rely on medical grade silicone sheets that meet USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 requirements to ensure safety and regulatory compliance.
A major advantage of medical grade silicone sheets is their ability to maintain flexibility, resilience, and mechanical stability across a wide temperature range. They withstand repeated sterilization cycles, including autoclave, gamma, and EtO, without degrading or discoloring. Their resistance to UV, ozone, and environmental aging makes them ideal for long‑term device performance. Common uses include seals and gaskets for medical equipment, pump diaphragms, fluid‑handling components, patient‑contact interfaces, and sensor pads. These sheets are available in multiple durometers, thicknesses, and translucent or custom colors, and can be die‑cut into precise geometries.
ElastaPro calendars medical grade silicones into solid elastomers that can be die cut into parts for peristaltic pumps, insulin pumps, and other types of medical devices and equipment. This process creates flexible, durable silicone sheets that can be precisely controlled for thickness, texture, and other properties.
Medical grade solid silicone sheet are available in:
- Durometers: 10 to 70 Shore A
- Thicknesses: .007” to .500”
- Widths: Up to 60”
- Colors: While typically translucent, various colors are available
These products are Made to Order and supplied in a gloss or matte finish. ElastaPro can also supply you with silicone rolls that we can slit-to-width for automated cutting operations.
Medical Grade Silicone Continuous Rolls
Medical grade continuous silicone rolls provide a highly efficient way for manufacturers to process silicone materials at scale while maintaining the purity and compliance required for healthcare applications. Unlike pre‑cut sheets, continuous rolls offer long, uninterrupted lengths of platinum‑cured silicone, allowing converters to streamline die‑cutting, slitting, laminating, and automated fabrication workflows. This format reduces waste, improves throughput, and ensures consistent material properties across every linear inch.
Because medical grade continuous rolls are produced from high‑purity, addition‑cure silicone, they exhibit extremely low extractables and meet key standards such as USP Class VI, ISO 10993, and FDA 21 CFR 177.2600. Their stability under sterilization—autoclave, gamma, and EtO—makes them suitable for components that require repeated cleaning or long‑term patient contact.
Medical grade silicone continuous rolls are commonly used for medical gaskets, fluid‑handling seals, pump diaphragms, wearable device interfaces, and precision‑cut components for diagnostic and therapeutic equipment. Available in a range of durometers, thicknesses, and translucent or custom colors, medical grade continuous rolls support tight‑tolerance converting and high‑volume production.
Medical grade silicone continuous rolls are available with
- Roll Length Control: The 33″ maximum roll length ensures manageable handling while supporting continuous production.
- Sheet Slitting: Rolls can be slit to precise widths, enabling tailored solutions for automated cutting, gasketing, or sealing operations.
- PSA Adhesive Application: Adhesive backing reduces assembly complexity, eliminates secondary bonding steps, and ensures reliable installation.
For engineers and OEMs, medical grade continuous rolls deliver a combination of purity, scalability, and manufacturing efficiency that helps accelerate device development while maintaining strict regulatory confidence.
Medical Grade Silicone for Molding
In addition to medical grade silicone sheets, ElastaPro offers uncured silicone compound that arrives ready-to-mold. Our materials are supplied rolled-up off the mill or in sheet form with a poly liner. Whether you need medical grade silicone sheets, continuous rolls, or medical grade silicone for molding, we’d welcome your inquiry.
