Medical Grade Silicone Gasket
Manufacturer & Custom Solutions
Medical Grade Silicone Gasket
Our medical grade silicone gaskets are manufactured with USP Class VI materials and can be provided with full biocompatibility documentation. They withstand autoclave, gamma and EtO sterilization for reusable medical devices.
FDA 21 CFR 177.2600
Rubber Articles Intended for Repeated Use
LFGB 30&31
EU Food Contact Materials
USP Class VI / ISO 10993
Biocompatibility of Medical Devices
RoHS / REACH
Environmental Compliance
UL 94
Flammability of Plastic Materials
Built to Your Exact Spec
Custom Silicone Gaskets Options
| Image | Product | Type | Short Info | Action |
|---|---|---|---|---|
 | DIN 32676 Silicone Gasket | Standard & Size | DIN 32676 tri-clamp silicone gaskets, FDA food grade, full size range in stock at ZSR factory. | View Details |
 | AS568 Standard Silicone Gaskets | Standard & Size | AS568 standard-size silicone gaskets for groove-based sealing applications. | View Details |
 | DIN 3869 Silicone Sealing Ring | Standard & Size | DIN 3869 profile sealing rings in silicone for hydraulic ports, working from -60°C to +200°C. | View Details |
 | EN 1514-1 Silicone Gasket | Standard & Size | EN 1514-1 silicone flat gaskets for PN flanges, IBC and FF types, standard and custom sizes. | View Details |
 | Custom Die Cut Silicone Gaskets | Standard & Size | Flat silicone gaskets cut to any shape from sheet stock. Precision cutting for exact fits. | View Details |
 | ISO 7483 Silicone Gasket | Standard & Size | Silicone gaskets to ISO 7483 for ISO 7005 flanges, made for international projects and tenders. | View Details |
 | Custom Molded Silicone Gaskets | Standard & Size | Three-dimensional silicone gaskets made by compression or injection molding. For complex sealing shapes. | View Details |
 | ISO 1127 Silicone Gasket | Standard & Size | Sanitary silicone gaskets matched to ISO 1127 stainless steel tube sizes for food and pharma lines. | View Details |
 | Standard Flange Silicone Gaskets | Standard & Size | Silicone gaskets cut to fit pipe flanges. Matches ANSI, DIN and JIS bolt patterns. | View Details |
 | B16.21 Silicone Gasket | Standard & Size | ZSR makes silicone gaskets to ASME B16.21, ring type and full face type, for Class 150 to 2500 pipe flanges. | View Details |
 | ISO 2852 Silicone Gasket | Standard & Size | ISO 2852 silicone clamp gaskets for food industry couplings, FDA grade, factory direct from ZSR. | View Details |
 | Tri-Clamp / Sanitary Silicone Gaskets | Standard & Size | Hygienic silicone gaskets for food and pharmaceutical pipe connections. CIP and SIP compatible. | View Details |
 | B16.5 Silicone Gasket | Standard & Size | Silicone gaskets from ZSR sized to fit ASME B16.5 flanges, NPS 1/2 to 24 inch, Class 150 to 2500. | View Details |
 | Metric Size Silicone Gaskets | Standard & Size | Metric dimension silicone gaskets for international equipment standards. | View Details |
 | DIN 7603 Silicone Sealing Ring | Standard & Size | Flat silicone sealing rings made to DIN 7603 for screw plugs, banjo bolts and threaded fittings. | View Details |
 | DIN 2690 Silicone Gasket | Standard & Size | Silicone flat gaskets to DIN 2690 / EN 1514-1 dimensions for PN6 to PN40 flanges, food grade available. | View Details |
 | DIN 2691 Silicone Gasket | Standard & Size | Silicone gaskets made to DIN 2691 for tongue and groove flanges PN10 to PN160, ideal for plant repair. | View Details |
 | DIN 11851 Silicone Gasket | Standard & Size | Food grade silicone gaskets for DIN 11851 sanitary unions, DN10 to DN150, FDA material. | View Details |
 | FDA Food Grade Silicone Gasket | Grade | Food-safe silicone gaskets for processing equipment. FDA-compliant and taste-neutral. | View Details |
 | Medical Grade Silicone Gasket | Grade | Biocompatible silicone gaskets for medical devices. Sterilizable with full documentation. | View Details |
 | Industrial Grade Silicone Gasket | Grade | General-purpose silicone gaskets for industrial sealing. Reliable, durable and cost-effective. | View Details |
 | High Temperature / Heat Resistant Silicone Gaskets | Special Function | Heat-resistant silicone gaskets rated for continuous use above 200°C. For ovens and furnaces. | View Details |
 | Flame Retardant Silicone Gaskets | Special Function | Self-extinguishing silicone gaskets meeting UL 94 V-0. For fire-safety applications. | View Details |
 | Solid Silicone Rubber Gaskets | Materials | Solid silicone rubber gaskets with excellent compression set resistance and long service life. | View Details |
 | Fluorosilicone (FVMQ) Gaskets | Materials | Fuel and solvent-resistant silicone gaskets for chemical processing and automotive applications. | View Details |
 | Transparent / Clear Silicone Gaskets | Color | Clear silicone gaskets for visible sealing and light-transmitting applications. | View Details |
 | Black / White Silicone Gaskets | Color | Standard black and white silicone gaskets. Fastest delivery from stock. | View Details |
Medical Grade Standards
Medical grade silicone is defined by three pillars. Here is what each one really means:
USP Class VI — the most stringent biocompatibility class of the U.S. Pharmacopeia. To pass, the material must clear three animal-based tests with no toxic reaction:
USP Class VI testing must be done by an independent laboratory — no supplier can self-certify it.
ISO 10993 — the international framework for biological evaluation of medical devices. It is risk-based: the required tests depend on how the part contacts the body and for how long. The "big three" tests almost every medical silicone needs are cytotoxicity (ISO 10993-5), sensitization and irritation (ISO 10993-10), plus systemic toxicity (ISO 10993-11) for longer contact.
Sterilization compatibility — Medical devices are sterilized before use — and the gasket must survive it. Our medical grade silicone handles all common methods without losing its properties: autoclave (steam), gamma radiation, and ethylene oxide (EtO).
Medical vs Food vs Industrial
Factor | Medical Grade | Food Grade | Industrial Grade |
|---|---|---|---|
Protects | The human body (contact with skin, tissue, fluids, medicine) | Food and beverages | Machines and equipment |
Key Standards | USP Class VI, ISO 10993, ISO 13485 | FDA 21 CFR 177.2600, LFGB | General industrial standards |
Testing | Biocompatibility: cytotoxicity, sensitization, irritation, systemic toxicity, implantation | Migration & extraction into food simulants | Size, hardness, physical performance |
Cure System | Platinum cured, low extractables | Platinum or peroxide | Peroxide |
Production | Cleanroom, contamination-controlled | Clean workshop | Standard workshop |
Documentation | USP Class VI / ISO 10993 reports, CoA, full lot traceability | Declaration of Compliance + CoA | Basic batch record |
Price | Highest | Medium | Lowest |
The simple rule
Food grade is tested for what food touches; medical grade is tested for what the human body touches — a much deeper level of biological testing. Never downgrade a medical seal to food grade to save cost. And never pay for medical grade when the gasket only seals a machine.
Typical Medical Applications
Our medical grade silicone gaskets seal the devices that keep people healthy:
Respiratory devices
ventilators, CPAP machines, oxygen concentrators, breathing masks
Surgical instruments and equipment
housings, handpieces, and reusable devices that face repeated autoclave cycles
Wound care devices
negative-pressure therapy units, dressing equipment, skin-contact devices
Diagnostic equipment
analyzers, imaging devices, lab instruments, sample-handling systems
Drug delAvery systems
insulin pumps, infusion devices, inhalers,
dosing equipment
Pharmaceutical production
bioprocess equipment, filling lines, and sanitary seals in drug manufacturing
Every medical gasket ships with the documentation your regulatory team needs — material test reports, CoA, and batch traceability — ready to support your device submission.
What Is Medical Grade Silicone?
Medical grade silicone is the purest, most controlled form of silicone rubber. It starts with high-purity raw materials, is cured with a platinum catalyst to leave almost no chemical residue, and is produced under strict, documented quality controls. Most importantly, it is tested and proven safe for contact with the human body — with skin, with tissue, and with body fluids. It is the same silicone chemistry that industry uses, refined to a level where hospitals, laboratories, and device makers can trust it with patients.
How LSR Is Made at ZSKey Properties of Medical Grade Silicone
