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Custom Medical Silicone Corrugated Tube | OEM Silicone Tubing from China Suppliers & Factory
Product Detail
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Material
Medical-Grade Silicone
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Color
Can be Customized
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MOQ
1,000 Pieces
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Dimensions
Custom Sizes
| 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 (FAQ)
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What is Metal Overmolding Medical Silicone Tube, and how is it manufactured?
Metal Overmolding Medical Silicone Tube is produced by encapsulating a metal insert or component within medical-grade LSR (Liquid Silicone Rubber) using a Liquid Silicone Injection Molding (LSR/LIM) process. This method ensures a secure, flash-free bond between the metal substrate and the silicone, delivering precision parts suitable for demanding medical applications.
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Is the silicone material safe for medical and body-contact applications?
Yes. The silicone used is Platinum-Cured Medical Grade LSR, fully compliant with USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 standards. It is non-toxic, non-allergenic, and biocompatible, making it suitable for long-term skin contact, fluid contact, and implantable or wearable medical device applications.
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Can the product be customized in terms of size, color, and hardness?
Absolutely. The product supports full OEM & ODM customization. Hardness can be tailored from Shore 10A to 80A, colors can be matched to standard Pantone shades or custom specifications, and dimensions are fully customizable to meet your project requirements. Surface finishes — including medical smooth, textured, or custom profiles — are also available.
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What sterilization methods are compatible with this silicone tube?
The medical silicone tube supports a wide range of sterilization methods, including steam autoclaving (up to +200°C), EO (ethylene oxide) sterilization, gamma radiation, and e-beam sterilization. With a compression set of ≤ 20% after 22 hours at 175°C, the product maintains its seal integrity across repeated sterilization cycles.
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What is the minimum order quantity (MOQ) and lead time for prototypes?
The minimum order quantity (MOQ) is 1,000 pieces for standard production orders. For prototype development, the typical lead time is 2–4 weeks, depending on the complexity of the design and tooling requirements. Our team offers full support from initial design through to prototyping, validation, and mass production.
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What quality certifications and standards does the manufacturing process comply with?
Our manufacturing facility is certified to ISO 13485:2016, the international standard for quality management systems in medical device manufacturing. This ensures full traceability, strict process controls, and documentation at every stage of production. Dimensional tolerances conform to ISO 20457 (DIN 7715), meeting the precise requirements of medical component manufacturing.