Liquid Silicone Medical Components

Liquid silicone medical components are precision medical-grade parts manufactured from medical-grade Liquid Silicone Rubber (LSR) through platinum-catalyzed liquid injection molding. They are mainly used for sealing protection, fluid transmission, insulation buffering and flexible connection of various medical instruments and equipment. Compared with traditional plastic and rubber parts, they have better biocompatibility, temperature resistance and elasticity, can directly contact human skin, body fluids and medical reagents, and are indispensable core supporting parts in high-end medical devices, diagnostic equipment and nursing consumables.

Core Advantages

● Medical-grade biocompatibility: Made of medical-grade liquid silicone raw materials, non-sensitizing, free of harmful substance precipitation, safe for contact with human tissues and body fluids, meeting clinical application requirements.
● Excellent weather and sterilization resistance: Resistant to 121℃ high-temperature and high-pressure autoclaving, ethylene oxide, ultraviolet radiation and other sterilization methods; resistant to acid, alkali and medical disinfectants, not easy to age, yellow or deform after long-term use.
● High precision molding: Liquid silicone has excellent fluidity, enabling the molding of complex thin-walled and micro-structure products with tight dimensional tolerances, adapting to the high-standard assembly requirements of precision medical equipment.
● Stable elastic sealing performance: Good resilience and low compression set, maintaining stable sealing performance even under long-term compression, effectively reducing the risk of liquid or air leakage in medical equipment.
● Eco-friendly and non-toxic platinum vulcanization: Adopting platinum-catalyzed vulcanization process, free of plasticizers, bisphenol A and heavy metals, odorless and residue-free, complying with medical environmental protection and safety standards.

Technical Specifications

Item	Parameter Index
Main Material	Medical-grade Liquid Silicone Rubber (LSR)
Hardness Range	30°~70° Shore A (customizable on demand)
Working Temperature	-40℃ ~ 200℃
Dimensional Tolerance	±0.02mm ~ ±0.1mm (subject to product structure evaluation)
Vulcanization Method	Platinum-catalyzed vulcanization
Compliance Standards	ISO 13485, FDA 21CFR177.2600, GB/T 16886
Standard Colors	Transparent, semi-transparent, medical blue (customizable by Pantone number)
Molding Process	Liquid silicone injection molding
Production Environment	Class 10000 clean workshop

Application Fields

● Respiratory and anesthesia equipment: silicone cushions for respiratory masks, respiratory circuit sealing rings, one-way valve discs, mask airbags, etc.
● Infusion and blood transfusion instruments: silicone catheter connectors, fluid stop valves, infusion pump tubes, bottle stopper seals, drainage tube accessories, etc.
● Surgical instruments: surgical instrument handle sleeves, trocar seals, irrigator silicone tips, tourniquet accessories, etc.
● Aesthetic and rehabilitation equipment: silicone sleeves for beauty instrument probes, rehabilitation aid cushions, electrode silicone sheets, negative pressure drainage accessories, etc.
● Diagnostic and testing equipment: silicone stoppers for sampling tubes, sealing gaskets for detectors, silicone parts for reagent pumps, sample processing consumable accessories, etc.

The full range of liquid silicone medical components can cover diverse medical scenarios from routine care to precision diagnosis, and support targeted development according to equipment application requirements.

Component Category	Core Function	Typical Application Scenarios	Standard Hardness Range	Compatible Sterilization Methods
Medical Silicone Seals & Gaskets	Static/dynamic sealing, prevent liquid & gas leakage	Respiratory anesthesia equipment, diagnostic analyzers, medical infusion pumps	40°~60° Shore A	Autoclave, Ethylene Oxide (EO), UV
Liquid Silicone Catheter Connectors	Flexible pipeline connection, fluid conduction, sealing transition	Infusion & transfusion devices, negative pressure drainage, aesthetic medicine tubing	50°~70° Shore A	Autoclave, Ethylene Oxide (EO)
Silicone One-way Valve Discs	One-way conduction, prevent fluid/gas backflow	Breathing circuits, precision infusers, syringe accessories	30°~50° Shore A	Autoclave, Ethylene Oxide (EO), Gamma Irradiation
Respiratory Mask Silicone Cushions	Facial sealing, pressure relief, wearing comfort improvement	Respiratory masks, anesthesia masks, non-invasive oxygen masks	30°~45° Shore A	Autoclave, Ethylene Oxide (EO)
Sampling Tube / Reagent Bottle Silicone Stoppers	Container sealing, leak-proof, puncture-compatible	Blood collection tubes, sample tubes, reagent storage bottles	45°~65° Shore A	Autoclave, Ethylene Oxide (EO), Gamma Irradiation
Surgical Instrument Silicone Sleeves	Anti-slip grip, insulation protection, shock absorption	Surgical instrument handles, diagnostic probes, trocars	50°~70° Shore A	Autoclave, Ethylene Oxide (EO)

Certifications & Quality Assurance

● System certification: The factory has passed ISO 13485 medical device quality management system certification, and the production process strictly follows medical product control specifications.
● Material certification: Raw materials have passed US FDA food and drug contact certification and EU LFGB testing. We can provide biocompatibility test reports for cytotoxicity, skin sensitization and skin irritation.
● Process control: Exclusive Class 10000 clean production workshop with dust-free operation throughout the whole process. Multiple quality inspection checkpoints are set up from raw material incoming inspection, production process to finished product delivery.
● Batch traceability: A complete production batch traceability system has been established, with full traceability of raw material batches, production parameters and testing records, ensuring the safety and traceability of medical products.

Competitive Advantages | Why Choose Us?

● Direct factory supply: With over 22 years of experience in liquid silicone molding, we own our own production plant and a full set of precision injection molding equipment. There is no middleman markup, giving us dual advantages in cost and delivery.
● In-house mold capability: We have our own mold design and processing workshop, which can quickly complete the development and optimization of complex-structure medical molds, greatly shortening the product development cycle.
● Compliant production environment: Exclusive Class 10000 clean workshop and dedicated medical product production line, different from ordinary industrial silicone workshops, meeting the production environment requirements of medical components.
● Full-dimensional customization support: Customizable from raw material formula, hardness, color to product structure, which can efficiently respond to niche and customized demands for liquid silicone medical components.
● Strict quality control system: Equipped with professional dimensional testing and performance testing equipment, key products are 100% inspected to ensure uniform size and stable performance of each batch.
● Fast response and delivery: We keep multiple grades of medical-grade liquid silicone raw materials in stock. Conventional samples are delivered within 3-7 days, mass production orders have stable lead time, and urgent orders can be arranged for priority production.

After-sales Service

● Each customer is assigned a dedicated account manager to follow up demand communication, order progress and after-sales coordination throughout the whole process, ensuring efficient communication.
● Business inquiries are responded within 2 hours on working days; after-sales quality issues will be provided with verification results and solutions within 24 hours.
● Free technical support is provided, including product selection suggestions, structure optimization evaluation and assembly adaptation guidance, to help customers reduce development risks.
● Regular return visits on product usage after order delivery, collecting product feedback and continuously optimizing production processes and product performance.

Packaging & Shipping

● Packaging method: Inner layer uses food-grade PE bags or dust-free vacuum packaging, outer layer uses thickened pressure-resistant cartons; sterile packaging, anti-static packaging and custom color boxes are available on demand.
● Labeling specification: The outer package is marked with product model, production batch, quantity, production date and traceability code, facilitating warehouse management and batch traceability.
● Logistics channels: Support express delivery, trucking, sea freight, air freight and other transportation methods, and can cooperate with customer-specified freight forwarders and shipping ports.

● Delivery lead time: Conventional stock samples are shipped within 3 days; mold opening and sampling take 3-7 days; mass production orders take 15-25 days, subject to product complexity and order quantity.

Sample & Testing Support, Warranty & Return Policy

● Sample support: We can provide samples of existing standard mold specifications. A small sample fee is charged for some products, which can be deducted from subsequent bulk orders as agreed.
● Testing support: Raw material test reports, factory dimensional and appearance inspection reports can be provided with the goods; we can assist customers in handling third-party special tests such as biocompatibility and sterilization resistance.
● Warranty period: Under the premise of no man-made damage and improper use, the product warranty period is 12 months.
● Return and exchange rules: If the product has factory quality problems such as dimensional inconsistency and performance non-compliance, it can be returned, exchanged or reworked free of charge after confirmation by both parties; problems caused by changes in customer demand for customized products shall be negotiated by both parties.

Customization & Production Process

1. Demand communication: Customers provide 2D/3D drawings, physical samples or demand descriptions, and clarify core requirements such as material, hardness, tolerance and certification.
2. Solution evaluation: The engineering team evaluates the product structure and process feasibility, and provides molding solutions, quotations and estimated lead time.
3. Mold development: After the solution is confirmed, mold design and processing are started, and raw material preparation and production scheduling are carried out simultaneously.
4. Sample confirmation: Trial molding and sample delivery are conducted. Customers conduct assembly and performance tests, and adjustments and optimizations can be made as needed.
5. Mass production: After final sample confirmation, mass production is arranged, and the whole process is controlled in accordance with ISO 13485 system.
6. Quality inspection and testing: Finished products are subject to 100% inspection or sampling inspection according to standards, and factory inspection reports are issued.
7. Packaging and delivery: After packaging as agreed, delivery is arranged, and the tracking number and traceability information are provided simultaneously.

Real Customer Experience

"We are a manufacturer focusing on respiratory medical devices. Previously, the silicone parts we purchased often had problems such as deformation after high-temperature sterilization and sealing failure, with poor batch stability. After cooperating with Aobo Silicone, they customized liquid silicone medical components according to our equipment parameters. In the early stage, their engineers also helped us optimize the corner structure, which reduced the assembly difficulty. The mass-produced products have high precision, and still maintain stable sealing performance after repeated high-pressure sterilization, with excellent batch consistency. Customer complaint rates have dropped significantly since launch. They also respond quickly to communication and can cooperate with our urgent production schedules during peak seasons. They are a very reliable medical component supplier." ------ Purchasing Director, a Medical Device Co., Ltd. in East China

FAQ

Q1: Are your silicone parts medical grade? Can you provide relevant certifications?

A: All our products are made of medical-grade liquid silicone raw materials. Our factory has passed ISO 13485 medical device quality management system certification. We can provide raw material FDA test reports, biocompatibility reports and system certification certificates, as well as batch factory inspection reports with the goods.

Q2: Do you support small-batch customization? What is the minimum order quantity?

A: We support small-batch trial production in the R&D stage. The specific MOQ depends on product size and structural complexity. For the pre-verification needs of medical customers, we can flexibly adjust the MOQ to reduce customers' development threshold.

Q3: How long does it take to open a mold and make samples? How about the cost?

A: The sampling cycle for conventional structure products is 3-7 days, and 7-10 days for complex precision products. Mold fee and sample fee will be charged for sampling, and the mold fee can be deducted as agreed after the bulk order is placed.

Q4: Can the product be sterilized by high temperature and high pressure? Will it deform?

A: Medical-grade liquid silicone can withstand 121℃ high-temperature and high-pressure autoclave sterilization, and is also compatible with ethylene oxide, ultraviolet and other sterilization methods. Under normal use, it is not easy to yellow or deform after repeated sterilization, with stable physical properties.

Q5: Can you customize according to our drawings? What materials do we need to provide?

A: We support full customization based on drawings or samples. You only need to provide 3D drawings in STEP/IGS format or physical samples, and inform us of material hardness, tolerance requirements, certification needs and estimated dosage. We will quickly evaluate the solution and quote for you.

Q6: Can the production environment meet the requirements of medical products?

A: We have an exclusive Class 10000 clean production workshop. Medical products are produced and packaged in a dust-free environment throughout the whole process, which meets the production environment control standards for medical components and can effectively reduce the risk of biological contamination of products.