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Custom Medical Silicone Corrugated Tube | OEM Silicone Tubing from China Suppliers and Factory
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
Q1
What certifications does your medical-grade silicone comply with?
Our medical-grade LSR (Liquid Silicone Rubber) is fully compliant with USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 standards. Our manufacturing facility is also ISO 13485:2016 certified, ensuring complete traceability throughout the production process for all medical device components.
Q2
Can the hardness and dimensions of the silicone tube be customized?
Yes. We offer a wide hardness range from Shore A 10 to Shore A 80, which can be tailored to match your specific component function — from ultra-soft seals to more rigid housings. Dimensions are fully custom to your design requirements. Please share your drawings or specifications, and our engineering team will provide a feasibility assessment.
Q3
Is the product suitable for sterilization processes such as autoclaving?
Absolutely. Our medical silicone tubes are rated for a temperature range of -50°C to +200°C, making them fully compatible with steam autoclave sterilization. Additionally, the compression set is ≤ 20% after 22 hours at 175°C, ensuring the product maintains its seal integrity even after repeated sterilization cycles.
Q4
What is the minimum order quantity (MOQ) and lead time for prototypes?
The standard MOQ for production orders is 1,000 pieces. For prototype and sample orders, lead time is typically 2–4 weeks depending on part complexity and tooling requirements. We support both OEM and ODM projects, from initial design and prototyping through to final validation, packaging, and logistics.
Q5
What bonding or secondary processing options are available for the silicone tube?
We offer a range of secondary operations including bonding to plastics, metals, or other substrates, pad printing, and sub-assembly. The metal overmolding process allows the silicone to be securely integrated with metal inserts during molding. Surface finish options include medical-smooth, textured, or fully custom profiles to meet functional or aesthetic needs.
Q6
What color and transparency options are available for the medical silicone tube?
The product is available in a full range from optically clear to fully opaque. Clear versions are particularly useful for fluid monitoring applications. Custom colors can be produced using medical-grade, non-migrating pigment masterbatches that comply with applicable medical standards. Standard Pantone color matching is also supported.