Medical Grade Silicone O-ring
Manufacturer & Custom Solutions
Medical Grade Silicone O-ring
Our medical grade silicone O-rings pass USP Class VI biocompatibility testing. They are manufactured in clean conditions and can be sterilized by autoclave, gamma or ethylene oxide. Ideal for medical devices, diagnostic equipment and drug delivery systems.
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 O-ring Options
| Image | Product | Type | Short Info | Action |
|---|---|---|---|---|
 | ISO 3601 Metric Silicone O-Rings | Standard & Size | Metric silicone O-rings manufactured to ISO 3601 dimensions. Fits international equipment groove standards. | View Details |
 | ISO 6149 Metric Silicone O-Rings | Standard & Size | Metric O-rings designed for hydraulic and pneumatic fluid power sealing applications under ISO 6149 standards. | View Details |
 | BS 1806 Silicone O-rings | Standard & Size | British Standard inch-size silicone O-rings. Common in UK and Commonwealth industrial equipment. | View Details |
 | DIN 3771 Silicone O-rings | Standard & Size | German metric standard O-rings for hydraulic and pneumatic sealing in European machinery. | View Details |
 | Custom Molded Silicone O-rings | Standard & Size | Custom-shaped silicone O-rings molded to your exact drawing or sample. No standard size limitations. | View Details |
 | AS568 Silicone O-rings | Standard & Size | Inch-size silicone O-rings that follow the AS568 standard. Widely used in North American machinery and hydraulic systems. | View Details |
 | AN6227 Silicone O-rings | Standard & Size | Aerospace-standard O-rings with small cross-section. Used in aviation and military-grade sealing. | View Details |
 | AN6230 Silicone O-rings | Standard & Size | Aerospace-standard O-rings specified under AN6230 for aviation and military-grade sealing. | View Details |
 | JIS B2401 Silicone O-Ring | Standard & Size | Japanese industrial standard O-rings commonly used in Asian-manufactured machinery and automotive equipment. | View Details |
 | FDA Food Grade Silicone O-Rings | Grade | Food-safe silicone O-rings compliant with FDA regulations. Safe for repeated food contact. | View Details |
 | Industrial Grade Silicone O-ring | Grade | General-purpose silicone O-rings for industrial sealing. Cost-effective with reliable performance. | View Details |
 | Medical Grade Silicone O-ring | Grade | Biocompatible silicone O-rings for medical devices. Passes USP Class VI and supports sterilization. | View Details |
 | Oil-Resistant / Fuel-Resistant Silicone O-Rings | Special Function | Modified silicone O-rings that resist swelling in oils, fuels and petroleum-based fluids. | View Details |
 | Metal Detectable Silicone O-Rings | Special Function | Food-safe silicone O-rings with metal-detectable additives. Protects production lines from contamination. | View Details |
 | High Temperature / Heat Resistant Silicone O-Rings | Special Function | Silicone O-rings that stay flexible at temperatures above 200°C. For ovens, engines and furnaces. | View Details |
 | VMQ Silicone O-Rings | Materials | Heat and cold-resistant silicone O-rings for food, medical, automotive, and industrial applications. | View Details |
 | Fiberglass Reinforced Silicone O-rings | Materials | High-strength silicone O-rings reinforced with fiberglass fabric. Withstands extreme heat and pressure. | View Details |
 | HCR / HTV / Solid Silicone Rubber O-rings | Materials | Durable solid silicone rubber O-rings made by compression molding. The standard choice for general sealing. | View Details |
 | Liquid Silicone Rubber (LSR) O-rings | Materials | Injection-molded liquid silicone rubber O-rings with tight tolerances and clean surfaces. Ideal for high-volume production. | View Details |
 | Platinum Cured Silicone O-rings | Materials | Ultra-clean silicone O-rings cured with platinum catalyst. Lower extractables for food and medical use. | View Details |
 | Fluorosilicone (FVMQ) O-rings | Materials | Fuel and oil-resistant silicone O-rings for aerospace, automotive and chemical applications. | View Details |
 | Transparent / Clear Silicone O-rings | Color | See-through silicone O-rings for visual inspection and clean-looking medical or food equipment. | View Details |
 | Black / White Silicone O-Rings | Color | Standard black and white silicone O-rings. The most common colors for industrial and food-grade applications. | View Details |
 | Pantone Colors Silicone O-rings | Color | Silicone O-rings in any Pantone color for branding, color-coding or aesthetic requirements. | View Details |
 | Custom Colors Silicone O-rings | Color | Silicone O-rings matched to your exact color sample or specification. | View Details |
Medical Grade Standards
At ZSR Silicone Parts, Medical Grade means our silicone O-rings meet the strictest biocompatibility and quality standards in the healthcare industry. Here are the key standards we follow.
USP Class VI
USP Class VI is a set of biological tests from the United States Pharmacopeia. It checks whether a material is safe for long-term contact with the human body. The tests include:
At ZSR, our medical-grade silicone compounds pass all three USP Class VI tests. We keep the test reports on file and can share them with your regulatory team.
ISO 10993
ISO 10993 is the international standard for biological evaluation of medical devices. It covers a wider range of tests than USP Class VI, including:
ZSR's medical-grade compounds are tested to the relevant sections of ISO 10993 based on your device's contact type and duration. We can provide ISO 10993 test summaries on request.
Additional Standards We Support
Standard | What It Covers | When You Need It |
|---|---|---|
EP 3.1.9 | European Pharmacopeia test for elastomeric closures | Pharmaceutical packaging and vial seals |
BFR XXI | German food and consumer goods regulation | European medical and baby care products |
RoHS / REACH | Restriction of hazardous substances | All medical devices sold in EU |
FDA Master File (MAF) | Material master file registered with FDA | FDA-reviewed medical device submissions |
Medical vs Food vs Industrial
All three grades use silicone rubber, but the rules for making them are very different. Use this table to pick the right grade for your project.
Feature | Industrial Grade | FDA Food Grade | Medical Grade |
|---|---|---|---|
Primary Use | Machinery, vehicles, electronics | Food and beverage equipment | Medical devices, implants, drug delivery |
Biocompatibility Testing | None | None (migration tests only) | USP Class VI + ISO 10993 required |
Curing System | Peroxide or platinum | Usually platinum | Almost always platinum |
Production Environment | Standard clean workshop | Food-safe area | Controlled cleanroom or dedicated line |
Extractables / Leachables | Not tested | Tested for food simulants | Tested for biological safety |
Odor & Taste | May have slight smell | No odor, no taste | No odor, no taste |
Sterilization Compatibility | Not required | Gamma or steam possible | Gamma, ETO, autoclave — validated |
Batch Traceability | Batch number only | Batch + material lot | Full chain: batch, material, mold, operator, date |
Documentation | Standard COA | FDA compliance letter | USP/ISO reports, COA, sterilization guide |
Shelf Life Control | Standard | Standard | Monitored and documented |
Price Level | Lowest | Medium | Highest |
When to Choose Medical Grade at ZSR:
When Food Grade Is Enough:
When Industrial Grade Works:
Typical Medical Applications
ZSR manufactures medical-grade silicone O-rings for devices where failure is not an option.
Device Category | Application | Why Medical Grade Matters |
|---|---|---|
Respiratory & Anesthesia | Oxygen mask seals, ventilator gaskets, CPAP mask cushions, nebulizer seals | Direct skin contact for hours. Must not irritate. Must survive repeated sterilization. |
Infusion & Drug Delivery | IV connector seals, syringe gaskets, infusion pump O-rings, dialysis machine seals | Touches blood and drugs. No extractables can enter the fluid path. |
Surgical Instruments | Handpiece seals, trocar gaskets, suction device O-rings, endoscope seals | Must tolerate autoclave sterilization (121°C steam). Must not degrade from cleaning chemicals. |
Diagnostic Equipment | Blood analyzer seals, urine test machine gaskets, sample handling robotics | Precision sealing with no contamination of test samples. |
Wound Care & Ostomy | Negative pressure wound therapy seals, ostomy bag connectors | Long-term skin contact. Needs soft, non-irritating material. |
Implantable Devices | Drug pump seals, pacemaker lead gaskets (short-term or long-term implant grades) | Highest purity. Long-term stability in body fluids. Requires special implant-grade silicone. |
Dental Equipment | Dental handpiece seals, water line gaskets, sterilization tray seals | Autoclave resistant. No taste transfer. |
Laboratory Equipment | Bioreactor seals, chromatography gaskets, filtration system O-rings | No contamination of cell cultures or purified samples. |
Note on Implantable Devices
ZSR produces medical-grade O-rings for short-term implants (under 30 days) and some long-term implant applications. For implants that stay in the body for years, we use special implant-grade silicone with additional purification and testing. Please contact our engineering team if your project involves implantation.
What Is Medical Grade Silicone?
Medical Grade silicone is silicone rubber that has been made, tested, and documented to be safe for contact with the human body. It is the purest form of silicone rubber, with the strictest controls on ingredients, production, and quality proof.
How It Differs from Other Grades
The base polymer is the same — polydimethylsiloxane. What changes is everything around it:
Key Properties of Medical Grade Silicone
Medical Grade Silicone is not just a label. It is a complete system of material selection, process control, testing, and documentation designed to protect patients. It costs more than industrial or food grade because every step requires extra care and proof. At ZSR, we understand that a medical O-ring is not just a seal — it is a safety component. We produce medical-grade O-rings with the same attention to detail that your device demands.