This liquid silicone medical sealing gasket is made of medical-grade LSR material, featuring excellent biocompatibility, resistance to autoclaving and chemical corrosion, with stable and long-lasting sealing performance. It fits the sealing needs of various medical devices, effectively prevents fluid leakage and bacterial invasion, and meets the strict safety standards of the medical industry.
Material
Medical-grade LSR
Hardness
Shore A 40-70
Temperature
Certifications
Applications
-40°C ~ +230°C
Colors
Black, White, Transparent, Customizable
# Medical Grade Liquid Silicone Medical Sealing Gasket for Medical Devices
Our Medical Grade Liquid Silicone (LSR) Medical Sealing Gasket is a high-precision sealing component engineered exclusively for critical medical device applications, manufactured via injection molding of medical-grade liquid silicone rubber that meets global biocompatibility standards. Designed to address the unique demands of the medical industry—including repeated sterilization, long-term biocompatibility, and consistent hermetic performance in high-stakes environments—this gasket outperforms conventional rubber, thermoplastic, and latex sealing solutions for medical use cases.
Core features include ultra-low extractable/leachable content, resistance to all common medical sterilization methods, and precision tolerance control as tight as ±0.02mm, ensuring a perfect fit even in miniaturized portable medical devices. Unlike traditional compression-molded rubber gaskets, our LSR gaskets have no flash, uniform material density, and zero porosity, eliminating the risk of fluid leakage or microbial ingress that could compromise patient safety. This product is optimized for both static sealing of device housings and dynamic sealing of moving components such as syringe plungers and surgical instrument actuators, delivering reliable performance across the entire product lifecycle of medical devices.
All gaskets are formulated with medical-grade LSR that complies with ISO 10993 and USP Class VI biocompatibility requirements, with no added plasticizers, latex, or harmful phthalates.
The gasket’s physical properties are optimized to maintain sealing force even after thousands of use cycles or sterilization rounds, with minimal compression set.
All gaskets are manufactured via high-precision liquid silicone injection molding under ISO 13485 certified cleanroom conditions, ensuring consistent part-to-part repeatability.
Unlike non-medical silicone gaskets, our formulation is free of carcinogenic byproducts, residual catalysts, and leachable additives that could cause adverse patient reactions. It passes the most stringent biological evaluation tests, making it safe for direct contact with intact skin, mucous membranes, and even short-term (≤30 days) contact with circulating blood and tissue. This eliminates the risk of inflammatory responses or cross-contamination between patients and medical devices.
The gasket retains 90% of its original sealing force and physical properties after 100+ autoclave cycles (134℃, 20min) or exposure to 50 kGy gamma irradiation, far outperforming EPDM or natural rubber gaskets which degrade after 10~20 sterilization cycles. This makes it ideal for reusable medical devices, reducing total cost of ownership for healthcare facilities by extending the service life of expensive equipment.
With tolerance control as tight as ±0.02mm, our gaskets eliminate gaps that could lead to fluid leakage, microbial ingress, or pressure loss in critical devices. The non-porous, fully cross-linked LSR structure creates a hermetic seal that maintains integrity even under pressure differentials of up to 10 bar, making it suitable for high-pressure applications such as infusion pumps and surgical insufflators.
The low compression set (<10% after 22h at 177℃) means the gasket does not permanently deform even after years of compressed installation, eliminating the need for frequent seal replacements. Its inherent lubricity also reduces friction in dynamic sealing applications, minimizing wear on both the gasket and mating device components, and extending the mean time between failures (MTBF) of medical equipment.
Our medical LSR sealing gaskets are used across a wide range of medical device segments, with application-specific formulation and hardness tuning available for each use case:
The optimal hardness of the gasket depends on its intended application:
We offer both standard off-the-shelf gaskets in common O-ring, rectangular, and custom profile formats, as well as fully custom designs tailored to your device’s mating interface:
Three material grade options are available to match your device’s risk classification and contact duration:
All our medical LSR sealing gaskets are manufactured in facilities certified to ISO 13485:2016 medical device quality management system standards, with full traceability from raw material batch to finished part shipment.
Each production lot undergoes rigorous quality control testing, including dimensional verification via coordinate measuring machine (CMM), biocompatibility batch testing, compression set testing, and sterilization compatibility validation. We provide a full device master record (DMR) package for all custom parts, including material test reports (MTRs), process validation reports, and sterilization validation data, to support your medical device regulatory submission (FDA 510(k), CE MDR, etc.).
All gaskets are packaged in double-layered, gamma-sterilizable PE bags in an ISO 8 cleanroom environment, with lot numbers and expiration dates clearly marked on each package. We offer optional pre-sterilization (EtO or gamma irradiation) before shipment for immediate use in sterile device assembly. Our product comes with a 2-year shelf life guarantee under recommended storage conditions (15~25℃, 40~60% relative humidity, away from direct sunlight and UV radiation), and we provide full technical support for gasket design, material selection, and application testing throughout your product development cycle.
