Hot Products
Custom Transparent Medical Silicone Tube | China Suppliers & Factory for High-Quality OEM Silicone Tubing
Product Detail
| Product Name | Silicone Tube Medical Use |
| 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 tube comply with?
Our silicone tubes are manufactured using Platinum-Cured LSR and comply with USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 standards. The production facility is also ISO 13485:2016 certified, ensuring full traceability throughout the medical device manufacturing process.
Q
Can the silicone tube be customized in size, color, and hardness?
Yes. We offer full customization options including dimensions (inner/outer diameter and wall thickness), Shore A hardness ranging from 10A to 80A, and colors based on standard Pantone references or your specific requirements. All pigments used are non-migrating and compliant with medical standards.
Q
Is the silicone tube suitable for sterilization processes?
Absolutely. The tube withstands temperatures from -50°C to +200°C, making it compatible with steam autoclave sterilization, EtO sterilization, and gamma radiation. Its compression set of ≤ 20% (tested at 175°C for 22 hours) ensures the tube maintains its seal integrity after repeated sterilization cycles.
Q
What is the minimum order quantity (MOQ) and lead time for prototypes?
The minimum order quantity is 1,000 pieces for standard production runs. For prototype development, the lead time is typically 2–4 weeks depending on the complexity of the design and the level of customization required.
Q
Do you offer OEM and ODM services for medical silicone tubes?
Yes, we provide full OEM and ODM services covering the entire product lifecycle — from initial design and prototyping through validation, regulatory support, custom packaging, and logistics. Our team works closely with clients to meet specific medical device requirements and compliance standards.
Q
What manufacturing process is used and how precise are the tolerances?
Our silicone tubes are produced using Liquid Silicone Injection Molding (LSR/LIM), which enables precision manufacturing of complex, flash-free parts suitable for high-volume medical applications. Dimensional tolerances conform to ISO 20457 (DIN 7715), ensuring consistent quality that meets strict medical component requirements.