Overview:
Our Personalized High Precision Medical LSR Gaskets and Seals are specially designed for medical devices, ensuring airtight, leak-proof sealing in critical applications. Made from liquid silicone rubber (LSR), these gaskets and seals are crafted to provide superior performance, durability, and safety. The gaskets are FDA-compliant and ISO 13485 certified, meeting the stringent standards required in medical device manufacturing. Manufactured using advanced LSR injection molding technology, these seals deliver exceptional precision and consistency, ensuring that your medical devices function optimally while maintaining the highest standards of safety and reliability. Our factory offers OEM and custom services, providing tailored solutions to meet your specific design, size, and material needs.
Specifications:
| Attribute | Details |
|---|---|
| Material | Liquid Silicone Rubber (LSR) |
| Certifications | ISO 13485, FDA Compliant, ROHS, REACH |
| Temperature Resistance | -50°C to +200°C |
| Hardness | 40–70 Shore A |
| Tolerance | ±0.05mm |
| Application | Medical devices, respiratory systems, infusion pumps, etc. |
| Custom Service | Fully customizable size, shape, and logo |
| MOQ | Small order accepted |
| Packing | Custom packaging available |
| OEM Service | Available for design and customization |
| Lead Time | 7–15 days (depending on quantity) |
| Sample Time | 3–5 days |
Benefits of Our Product:
- High Precision and Accuracy: Manufactured using LSR injection molding, ensuring tight tolerances and perfect fit for medical applications.
- Durability & Long-Term Performance: Liquid silicone rubber offers outstanding resistance to wear, tear, and environmental stress, ensuring longevity in demanding medical environments.
- Compliance with Medical Standards: Our gaskets and seals are FDA-compliant, ISO 13485 certified, and ROHS-approved, making them ideal for use in medical devices that require high-quality, safe components.
- Customizable to Specific Applications: We offer full OEM and custom services, tailoring the design, size, and material specifications to meet the unique requirements of your medical products.
Quality Assurance:
Our Personalized High Precision Medical LSR Gaskets and Seals undergo a rigorous quality assurance process to ensure compliance with industry standards. Each gasket and seal is produced in an ISO 13485 certified facility and is tested for:
- Dimensional Accuracy: Using CMM (Coordinate Measuring Machines) to ensure tight tolerances and precise measurements.
- Material Testing: Tensile strength and compression set tests ensure the durability and long-lasting performance of the LSR material.
- Leakage Testing: To verify that the seals maintain their leak-proof integrity in medical devices.
- Biocompatibility Testing: Ensuring that the LSR material is safe for use in medical environments.
- Thermal Resistance Testing: Verifying the gasket’s ability to withstand high and low-temperature variations without losing functionality.
These strict quality control measures guarantee that every gasket and seal is safe, effective, and reliable for use in medical devices.
Our Factory:
Our state-of-the-art manufacturing facility is equipped with advanced LSR injection molding machines and precision CNC machining capabilities, ensuring the highest level of accuracy and consistency for every gasket and seal. We operate ISO 13485 and FDA-compliant processes, ensuring full regulatory compliance in the production of medical-grade components. Our factory is supported by advanced inspection equipment such as 3D projectors, sealing integrity testers, durometers, and elasticity gauges, all operated by a skilled team of quality control professionals. Additionally, we leverage automation technologies such as AutoDryers, high-speed doming machines, and precision die-cutting systems to increase efficiency and maintain superior product quality at every stage of production.
