Custom Medical Silicone Disc Component from China Suppliers | High-Quality LSR Injection Molding 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
What certifications does Kingod's medical-grade LSR comply with?
Kingod's medical-grade LSR (Platinum-Cured) complies with USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 standards. Additionally, our quality management system is ISO 13485:2016 certified, ensuring full traceability throughout the medical device manufacturing process.
What hardness range is available for custom medical silicone components?
We offer a Shore A hardness range of 10A to 80A, fully customizable to match the specific functional requirements of your component — from soft, flexible seals to more rigid structural housings.
Can Kingod's silicone parts withstand sterilization processes?
Yes. Our medical silicone components are rated for temperatures from -50°C to +200°C, making them fully compatible with autoclave (steam) sterilization. The compression set value of ≤20% (22 hrs @ 175°C) also ensures that seal integrity is maintained across repeated sterilization cycles.
Does Kingod support OEM and ODM projects?
Absolutely. Kingod provides comprehensive OEM and ODM services, covering everything from initial design and prototyping to validation, packaging, and final logistics. Our engineering team offers end-to-end support to help you bring your medical device concept to production.
How long does it take to receive a prototype?
Prototype lead times are typically 2–4 weeks, depending on the complexity of the project. Our team will provide a more precise timeline after reviewing your specific design and technical requirements.
What customization options are available for branding and appearance?
Kingod supports precise Pantone color matching, private label printing, laser engraving, and fully bespoke packaging solutions. Surface finishes can be medical smooth, textured, or custom-designed to minimize bacterial adhesion or enhance grip and aesthetics.



