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Custom Medical Silicone Corrugated Tube | China Suppliers & Factory for OEM Silicone Tubing Solutions
Product Detail
| Product Name | Metal Overmolding Medical Silicone Tube Solution |
| Material | Medical-grade silicone |
| Color | Can be customized |
| MOQ | 1,000 pieces |
| Dimensions | Custom Sizes |
Product Description
| Parameter Category | Specification / Property | Standard / Value | Remarks / Application |
| Material & Certification | Material Grade | Medical Grade LSR (Platinum-Cured) | USP Class VI, ISO 10993, FDA 21 CFR 177.2600 compliant |
| Quality Management System | ISO 13485:2016 Certified | Full traceability for medical device manufacturing | |
| Physical Properties | Hardness (Shore A) | 10 A to 80 A | Customizable based on component function (e.g., soft seals, rigid housings) |
| Tensile Strength | ≥ 8 MPa | Ensures durability and tear resistance in dynamic applications | |
| Elongation at Break | ≥ 400% | Provides excellent flexibility and elongation for safety | |
| Tear Strength | ≥ 25 kN/m | Resists nicking and propagation of tears | |
| Performance Properties | Temperature Resistance | -50°C to +200°C | Suitable for autoclaving (steam sterilization) and cryogenic conditions |
| Biocompatibility | ✔ Certified | Non-toxic, non-allergenic, supports long-term skin/fluid contact | |
| Transparency | Optically Clear to Opaque | Available in full range; clarity ideal for fluid monitoring components | |
| Compression Set (22 hrs @ 175°C) | ≤ 20% | Maintains seal integrity after repeated sterilization cycles | |
| Surface & Processing | Surface Finish | Medical Smooth, Textured, or Custom | Minimizes bacterial adhesion; customizable for grip or aesthetics |
| Color | Natural, Standard Pantone, or Custom | Non-migrating, pigment masterbatches compliant with medical standards | |
| Secondary Operations | Bonding, Printing, Assembly | Can be securely bonded to plastics, metals, or other substrates | |
| Customization & Service | Manufacturing Process | Liquid Silicone Injection Molding (LSR/LIM) | Precision molding for complex, flash-free, high-volume parts |
| Tolerances | Tight, ISO 20457 (DIN 7715) | Meets medical component dimensional requirements | |
| Services Offered | Full OEM & ODM | From design & prototyping to validation, packaging, and logistics | |
| Lead Time for Prototypes | 2–4 Weeks | Subject to project complexity |
Frequently Asked Questions
Q
What certifications does the medical-grade silicone used in your overmolding solutions comply with?
A
Our medical-grade LSR (Liquid Silicone Rubber) is platinum-cured and compliant with USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 standards. Our manufacturing facility is also ISO 13485:2016 certified, ensuring full traceability throughout the production process.
Q
Can the hardness and dimensions of the metal overmolding silicone tube be customized?
A
Yes. We offer full customization of dimensions and Shore A hardness ranging from 10 A to 80 A to suit your specific application — whether you need soft sealing components or more rigid housings. Custom sizes are available with a minimum order quantity of 1,000 pieces.
Q
Is the silicone material safe for long-term contact with skin or bodily fluids?
A
Absolutely. Our silicone is certified biocompatible — it is non-toxic and non-allergenic, making it suitable for long-term skin contact and direct fluid-contact applications. It meets the stringent requirements of ISO 10993 for biological evaluation of medical devices.
Q
What sterilization methods are compatible with your silicone overmolded tubes?
A
Our silicone tubes are designed to withstand a wide temperature range of -50°C to +200°C, making them fully compatible with steam autoclaving (steam sterilization) as well as cryogenic storage conditions. The compression set value of ≤ 20% after 22 hours at 175°C ensures that seal integrity is maintained through repeated sterilization cycles.
Q
Do you support OEM and ODM services, and what is the lead time for prototypes?
A
Yes, we provide full OEM and ODM services covering everything from initial design and prototyping to validation, packaging, and logistics. Prototype lead time is typically 2–4 weeks, depending on the complexity of the project.
Q
Can the silicone tubes be bonded to metals, plastics, or other substrates?
A
Yes. Through secondary operations including bonding, printing, and assembly, our silicone components can be securely integrated with metals, plastics, and various other substrates. This makes them ideal for complex medical device assemblies requiring overmolded metal-silicone interfaces.