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Rubber gasket for medical use
LIXU
With over 15 years of expertise in high-precision rubber components, LIXU RUBBER specializes in flash free custom rubber gaskets for medical equipment. We deeply understand that medical devices demand absolute safety, ultra-precision, and compliance – even a tiny rubber flash can cause contamination or equipment malfunction, risking patient health. That’s why our flash free medical rubber gaskets are engineered with advanced mold design and precision molding technology, ensuring zero flash, consistent dimensional accuracy, and biocompatibility. We supply custom medical grade rubber gaskets to global clients, including medical device manufacturers, hospital equipment suppliers, and laboratory instrument brands, with full OEM/ODM support tailored to your drawings, sterilization requirements, and application scenarios. At LIXU RUBBER, we craft reliable medical rubber gaskets that meet the strictest industry standards, safeguarding your equipment performance and patient safety.
At Lixu Rubber, quality and compliance are non-negotiable for medical products. We operate GMP 100,000-class cleanrooms for production and packaging, and are certified with ISO 13485:2016, FDA, and USP Class VI. All flash free custom rubber gaskets comply with REACH, RoHS, and EU MDR standards, ensuring smooth export to USA, EU, and other global markets. Every batch undergoes 4-layer inspection: raw material purity testing, in-process flash monitoring, dimensional accuracy verification, and biocompatibility sampling – we provide full test reports and certification documents for every order.
Choosing the right medical-grade rubber material is critical for flash free gaskets – different materials vary in biocompatibility, sterilization resistance, and chemical stability. Below is a detailed comparison of the most suitable materials for medical equipment gaskets, helping you select the optimal option for your application:
| Rubber Material | Key Advantages (Medical Application) | Sterilization Compatibility | Suitable Medical Equipment |
|---|---|---|---|
| Medical-Grade Silicone Rubber | Excellent biocompatibility (ISO 10993), high-temperature resistance (-50℃ to +200℃), good elasticity, non-toxic odorless | Autoclaving, EO sterilization, gamma radiation | Insulin pumps, surgical instrument gaskets, endoscope seals, baby incubators |
| FKM (Viton) Rubber | Superior chemical resistance, high-temperature resistance (+200℃), excellent aging resistance, low outgassing | EO sterilization, dry heat sterilization | Laboratory analyzers, chemical delivery systems, medical gas equipment |
| EPDM Rubber (Medical Grade) | Good water/steam resistance, anti-ozone, low cost, FDA compliant, non-toxic | Autoclaving, EO sterilization | Dental equipment, hemodialysis machines, hospital sinks, steam sterilizers |
| TPR (Thermoplastic Rubber) | Soft touch, good flexibility, easy to process, recyclable, FDA compliant | EO sterilization, gamma radiation | Medical device handles, syringe gaskets, wearable medical device seals |
Our technical team will help you select the optimal material based on your equipment’s working conditions – most of our flash free custom rubber gaskets for medical equipment use medical-grade silicone or FKM, balancing biocompatibility and sterilization resistance.
| Parameter | Standard Specification | OEM Customization Range |
|---|---|---|
| Material | Medical-grade silicone, FKM, EPDM, TPR | Custom medical compounds (anti-coagulant, low-friction) |
| Hardness (Shore A) | 20° - 70° (soft to medium) | 15° - 80° (ultra-soft to firm) |
| Temperature Range | -50℃ to +200℃ | -60℃ to +230℃ (special silicone compound) |
| Size Range | Inner Diameter: 1mm - 100mm; Outer Diameter: 3mm - 150mm; Thickness: 0.1mm - 20mm | Custom sizes per CAD drawings/samples (miniature to large) |
| Tolerance | ±0.01mm | ±0.005mm (ultra-precision grade) |
| Certifications | ISO 13485, FDA 21 CFR 177.2600, USP Class VI, ISO 10993 | EU MDR, CE (MDD指令) per market requirements |
| Sterilization Compatibility | Autoclaving, EO, gamma radiation | Custom formulations for specific sterilization methods |
We offer flexible OEM/ODM services for medical rubber gaskets: custom packaging (sterile packaging available), brand printing, and technical documentation (test reports, certification packages).
Global shipping is available via DHL, FedEx, UPS, and air freight (for urgent orders), with delivery terms including FOB, EXW, CFR, and CIF. Standard flash free medical gaskets are in stock (delivery within 3-7 days); OEM custom orders take 7-10 days for samples and 15-25 days for mass production. Our sales team provides 24/7 professional service, answering your inquiries and providing technical solutions within 12 hours.
LIXU RUBBER offers a full range of medical-grade rubber components, including flash free custom rubber gaskets for medical equipment, medical grade silicone gaskets, FDA compliant rubber seals for medical devices, sterile rubber gaskets for surgical instruments, biocompatible rubber seals for hemodialysis machines, and ultra-precision flash free rubber gaskets for diagnostic equipment. All our products are engineered to meet the strictest medical industry standards, trusted by global medical device brands for safety, precision, and durability.
We achieve 100% flash free through three core technologies: first, optimized mold design with precise parting lines to avoid rubber overflow; second, advanced compression molding with real-time pressure and temperature control; third, automated visual inspection (with 0.001mm precision) for every gasket. No post-molding trimming is needed, ensuring zero flash and consistent quality.
Yes. Our standard medical-grade gaskets are compatible with autoclaving (121℃/134℃), EO sterilization, and gamma radiation. For special sterilization methods (e.g., dry heat sterilization at 180℃), we can customize material formulations to ensure the gaskets maintain elasticity and performance after 1000+ sterilization cycles.
Absolutely. All our flash free custom rubber gaskets for medical equipment comply with FDA 21 CFR 177.2600, USP Class VI, and ISO 13485 standards. We also provide EU MDR and CE (MDD指令) certifications for products exported to the European market, with full technical documentation to support your device certification.
Yes. We specialize in miniaturized medical rubber gaskets with inner diameters as small as 1mm and thickness as thin as 0.1mm. Our CNC precision molding machines ensure dimensional tolerance within ±0.005mm, and the flash free design fits perfectly with small device components, avoiding leakage and contamination.
Our MOQ for custom medical gaskets is 300 pieces, supporting small-batch customization for new product development. For mass production, the more you order, the more competitive the price. We also accept trial orders of 50-100 pieces for biocompatibility and performance testing.
Yes. Every batch of our medical rubber gaskets comes with a biocompatibility test report (ISO 10993) covering cytotoxicity, skin irritation, sensitization, and hemocompatibility (for blood contact products). We can also provide additional testing reports (e.g., extractable substances) according to your requirements.
Under normal clinical conditions and proper sterilization, our medical-grade silicone and FKM gaskets have a service life of 2-5 years. The service life may vary slightly based on sterilization frequency and working environment, but we guarantee no cracking, hardening, or performance degradation within the warranty period.
At Lixu Rubber, We provide high-quality flash free custom rubber gaskets for medical equipment at factory-direct prices. Whether you need standard medical gaskets or custom-designed ones for your medical devices,
Send us your requirements (size, material, hardness, sterilization method, quantity, drawings/samples) via email or WhatsApp. We will provide a detailed quote, material recommendation, and sample plan within 24 hours. Free samples are available for biocompatibility and performance testing – let’s build a long-term partnership based on quality and trust!
