Custom Medical Silicone Disc Components | LSR Injection Molding from China Suppliers and Factory
Parameters
| 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 |
Our Customization & Engineering Capabilities
Our expert engineering team provides end-to-end support to meet your specific design requirements:
Technical Specifications
Customizable shape, size, wall thickness, and shore hardness (Durometer).
Brand Integration
Precise Pantone color matching, private labeling (Logo printing/laser engraving), and bespoke packaging solutions.
Advanced Prototyping
From initial concept to mass production with tight tolerances.
Why Choose Kingod for Medical Silicone?
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Certified Quality: Kingod operates under strict quality management systems, being both ISO 9001 and ISO 13485 (Medical Devices) certified.
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LSR Expertise: We utilize medical-grade LSR materials that are fully compliant with global safety standards.
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Turnkey Manufacturing: A professional manufacturer offering scalable production to help your healthcare brand stand out in a competitive market.
Frequently Asked Questions
Q
What certifications does Kingod's medical-grade LSR comply with?
Kingod's medical-grade LSR (Liquid Silicone Rubber) is fully compliant with USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 standards. Our manufacturing quality management system is ISO 13485:2016 certified, ensuring complete traceability throughout the production process.
Q
What hardness range is available for custom medical silicone components?
We offer a customizable Shore A hardness range from 10A to 80A. This allows us to produce components suited to a wide range of medical applications — from ultra-soft seals and gaskets to firmer structural housings — depending on your specific functional requirements.
Q
Can Kingod's silicone parts withstand sterilization processes?
Yes. Our medical silicone components are designed to withstand temperatures from -50°C to +200°C, making them fully compatible with autoclave (steam sterilization) processes. Additionally, the compression set value of ≤ 20% at 175°C for 22 hours ensures long-term seal integrity through repeated sterilization cycles.
Q
What customization options are available for branding and appearance?
Kingod offers comprehensive brand integration services including precise Pantone color matching, private labeling through logo printing or laser engraving, and bespoke packaging solutions. Colors use non-migrating, medically compliant pigment masterbatches, and surface finishes can be smooth, textured, or custom-designed.
Q
How long does it take to receive a prototype?
Standard lead time for prototypes is 2–4 weeks, subject to the complexity of the project. Our team provides full OEM & ODM support — from initial design and prototyping through to validation, packaging, and logistics — ensuring a streamlined development process.
Q
Can medical silicone parts be bonded to other materials such as plastics or metals?
Absolutely. Kingod's silicone components can be securely bonded to plastics, metals, and other substrates through secondary operations including bonding, printing, and assembly. Our Liquid Silicone Injection Molding (LSR/LIM) process enables precision molding for complex, flash-free, high-volume parts that integrate seamlessly with multi-material assemblies.



