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
Medical Grade Silicone Gasket Specifications
Biocompatibility is documented, not claimed. Here is what we manufacture and the documentation that ships with every batch.
| Item | Range / Options | Test Standard |
|---|---|---|
| Biocompatibility | USP Class VI, ISO 10993 series (cytotoxicity, sensitization, irritation) | Batch test reports |
| Material | Platinum-cured HCR / HTV, LSR; no peroxide by-products | — |
| Hardness | 30 – 80 Shore A (customizable) | ASTM D2240 |
| Thickness | 0.5 – 25 mm (sheet die-cut) / by tool (molded) | ASTM D374 |
| Max Size | Up to 2000 mm outer diameter, any shape | — |
| Working Temp | -60°C to +230°C (special grades to +300°C) | — |
| Sterilization | Steam autoclave, gamma irradiation, EtO — material validated per method | ISO 11135 / ISO 17665 |
| Process | Die-cut (laser / water jet), compression molded, LSR injection | — |
| Documentation | COA per batch: hardness, specific gravity, cure state, USP Class VI compliance | — |
| Traceability | Compound lot → batch → shipment, full record retention | — |
| Standards | AS568, ISO 1127 / 2852, DIN 11851 / 32676, or custom drawing | — |
| MOQ | Die-cut: 100 pcs | Molded: 500 pcs | — |
| Lead Time | Prototype: 2–5 days | Production: 7–15 days | — |
Custom Medical Gaskets: Two Ways We Make Them
From single prototypes to validated production — same compound family, two manufacturing routes.
Custom Die Cut Medical Gaskets
Flat gaskets cut from USP Class VI sheet stock — fastest route for device housings, face seals and equipment flanges.
- Laser or water-jet cutting, tolerance to ±0.1 mm
- No tooling cost; any 2D geometry with bolt holes
- 0.5–25 mm thickness; cleanroom-compatible processing on request
- MOQ 100 pcs; samples in 1–3 days
Custom Molded Medical Gaskets
Three-dimensional seals for devices and instruments — designed, tooled and validated in-house.
- In-house mold design & making; steel-safe for design iterations
- Compression molding for solid profiles; LSR injection for precision and high volume
- Platinum-cured compounds with post-curing for lowest extractables
- MOQ 500 pcs; DFM feedback and validation samples included
Built to Your Exact Spec
Custom Silicone Gaskets Options
Six Silicone Grades, One Perfect Match
Every gasket starts with the right compound. Platinum-cured and peroxide-cured systems are available for all grades — we recommend platinum cure for food and medical contact.
| Grade | Hardness (Shore A) | Temperature | Compliance | Best For |
|---|---|---|---|---|
| Industrial VMQ | 30 – 80 | -60°C to +230°C | RoHS / REACH | General industrial sealing |
| FDA Food Grade | 30 – 70 | -60°C to +230°C | FDA 21 CFR 177.2600, LFGB | Food & beverage equipment |
| Medical Grade (Platinum) | 10 – 70 | -60°C to +230°C | USP Class VI / ISO 10993 | Medical devices & laboratory |
| High Temperature | 40 – 80 | up to +300°C | RoHS | Ovens, lighting, engine bays |
| Fluorosilicone (FVMQ) | 40 – 80 | -60°C to +200°C | RoHS | Fuel, oil & solvent exposure |
| LSR (Liquid Silicone) | 10 – 80 | -60°C to +230°C | FDA / medical grades | High-volume precision parts |
Built to Your Drawing, Down to 0.05 mm
Size, thickness, cross-section and geometry are fully custom. Send a drawing, a flange standard number, or a physical sample — we handle the rest.
| Item | Range / Options |
|---|---|
| Size Range | Built to your drawing; standard flange sizes DN10 – DN300 / NPS 1/2″ – 12″ (see standards table below) |
| Thickness | 0.5 – 10 mm sheet-cut; molded parts per drawing — common: 1.5 / 2 / 3 / 4.5 mm |
| Cross-Section | Flat / lip seal / custom profile |
| Custom Geometry | Bolt holes, slots, tabs, self-centering designs |
| Construction | Solid silicone / adhesive-backed / PTFE-laminated |
| Tolerance | Molded ±0.05 – 0.1 mm; die-cut ±0.2 mm |
Any Color Your Brand or Assembly Needs
We color-match silicone compounds to Pantone or RAL references, including translucent and transparent grades for visual inspection points.
Your Brand, Built Into the Part
Branding, part numbers and batch traceability — molded in, engraved or printed, without compromising the seal.
Four Processes, One Factory
Molding, cutting, injection and finishing under one roof — we match the process to your volume, geometry and tolerance target.
| Process | How It Works | Best For |
|---|---|---|
| Compression Molding | Pre-formed silicone pressed and cured in a heated mold | Medium volumes, large or thick gaskets |
| Die Cutting | Precision-cut from silicone sheet | Flat gaskets, fast turnaround |
| LSR Injection Molding | Liquid silicone injected into closed molds | High volumes, tight tolerances |
| Adhesive Backing | PSA tape laminated and die-cut to shape | Peel-and-stick assembly |
| Rapid Prototyping | Prototype tooling before production mold | Fit & function validation |
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.
Related Silicone Gaskets
| Image | Product | Type | Short Info | Action |
|---|---|---|---|---|
| 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 |
| AS568 Standard Silicone Gaskets | Standard & Size | AS568 standard-size silicone gaskets for groove-based sealing applications. | 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 |
| ISO 7483 Silicone Gasket | Standard & Size | Silicone gaskets to ISO 7483 for ISO 7005 flanges, made for international projects and tenders. | 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 1127 Silicone Gasket | Standard & Size | Sanitary silicone gaskets matched to ISO 1127 stainless steel tube sizes for food and pharma lines. | View Details |
|
| Custom Molded Silicone Gaskets | Standard & Size | Three-dimensional silicone gaskets made by compression or injection molding. For complex sealing shapes. | 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 |
| Standard Flange Silicone Gaskets | Standard & Size | Silicone gaskets cut to fit pipe flanges. Matches ANSI, DIN and JIS bolt patterns. | 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 |
| Tri-Clamp / Sanitary Silicone Gaskets | Standard & Size | Hygienic silicone gaskets for food and pharmaceutical pipe connections. CIP and SIP compatible. | 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 |
| Metric Size Silicone Gaskets | Standard & Size | Metric dimension silicone gaskets for international equipment standards. | 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 |
| 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 |
| 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 |
| 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 |
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
Where Medical Grade Gaskets Are Used
The same USP Class VI compound family, qualified for each use environment.
Medical Devices & Equipment
Seals for diagnostic housings, surgical instrument gaskets, pump and valve seals in patient-contact equipment. Sterilizable by the method your device supports.
Pharma & Bioprocessing
Tri-Clamp (ISO 2852), DIN 11851 and ISO 1127 union gaskets for bioreactors, filling lines and CIP/SIP systems. High-purity platinum-cured compounds with extractables documentation.
Lab & Life Science
Autoclave-compatible seals for analyzers, incubators and sample handling equipment. For food-contact or lower-spec applications, our FDA food grade gaskets offer the same tooling at lower cost.
How to Verify a Medical Grade Silicone Supplier
"Medical grade" is not a regulated label — anyone can print it. These five documents separate a real medical supplier from a marketing claim.
| Document | What It Proves | What to Look For |
|---|---|---|
| USP Class VI test report | The specific compound passed USP <88> biological reactivity tests (systemic injection, intracutaneous, implantation) | Report matches the compound lot, not just a base polymer datasheet; dated within a reasonable re-test window |
| ISO 10993 series data | Cytotoxicity, sensitization and irritation testing for device applications | Tests on the cured elastomer, not raw ingredients |
| Certificate of Analysis (COA) | Batch-level hardness, specific gravity and cure state | Every shipment, every batch — not available "on request only" |
| Sterilization validation | Material properties retained after your sterilization method | Data for autoclave / gamma / EtO specific to the compound |
| Lot traceability & change control | Any compound change is notified and re-validated before shipment | Written change-control agreement for regulated products |
ZSR provides all five for medical projects: batch USP Class VI reports, COA with every shipment, sterilization data, and documented change control. See ZSR certifications or ask for a sample documentation pack with your quote.
Medical Grade Silicone Gasket FAQs
Answers to the questions medical buyers ask before qualifying a supplier.