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Custom Medical Silicone Corrugated Tube Manufacturing | China Suppliers and Factory for OEM Silicone Tubing
ⓘ 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
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Q What certifications does the medical-grade silicone material comply with?Our medical-grade LSR (Liquid Silicone Rubber) is platinum-cured and complies 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.
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Q Can the hardness and dimensions of the silicone tube be customized?Yes. The Shore A hardness can be adjusted from 10 A to 80 A depending on your application requirements — whether you need soft, flexible seals or more rigid structural components. Dimensions are fully custom-engineered to your design specifications.
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Q Is this product suitable for sterilization processes such as autoclaving?Absolutely. The silicone material withstands temperatures from -50°C to +200°C, making it fully compatible with steam sterilization (autoclaving) as well as cryogenic storage conditions. The low compression set (≤ 20% at 175°C/22 hrs) ensures seal integrity is maintained after repeated sterilization cycles.
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Q What is the minimum order quantity (MOQ) and lead time for prototypes?The minimum order quantity for production runs is 1,000 pieces. For prototype development, the typical lead time is 2–4 weeks, depending on the complexity of the project design and tooling requirements.
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Q Do you support OEM and ODM services for custom medical silicone components?Yes, we provide full OEM and ODM services. Our support covers the entire product lifecycle — from initial design and prototyping through validation, regulatory compliance assistance, custom packaging, and final logistics. We work closely with clients to deliver tailored solutions that meet their exact medical device requirements.
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Q Can the silicone tube be bonded to metal or plastic components?Yes. Through our metal overmolding process and secondary bonding operations, the silicone can be securely integrated with metals, plastics, and other substrates. This makes it ideal for complex medical assemblies that require a reliable, long-lasting bond between dissimilar materials.