ODM Custom Medical Grade LSR Components | China Suppliers & Factory for Precision Silicone Parts Exporters, Factory
Product Description
Product Overview
Shenzhen Sunmy Hardware Co., Ltd. specializes in high-precision, custom-engineered Medical Grade Liquid Silicone Rubber (LSR) components. Utilizing state-of-the-art LSR injection molding technology, we manufacture complex, biocompatible silicone parts tailored for critical medical, maternal, oral, and respiratory applications. Our end-to-end capabilities span from precise tool design and steel selection to cleanroom-compatible production, ensuring that every product meets the rigorous standards of the international medical device industry.
Whether you require medical masks, dental guards, maternal nipple shields, or feminine hygiene products like menstrual cups, our advanced engineering team delivers flawless execution based strictly on your 2D/3D technical drawings.
Manufacturing & Process Insights
Liquid Silicone Rubber (LSR) injection molding involves a sophisticated two-part platinum-cured system mixed and injected into a heated mold cavity. Unlike traditional compression molding, LSR injection molding offers superior dimensional stability, flash-less production, and unmatched consistency for high-volume manufacturing runs.
To guarantee high wear resistance and a prolonged tool life of 1,000,000 to 3,000,000 shots, we utilize premium core and cavity steel materials, including LKM, S136H, P20, and 718H. Our tools feature advanced cold runner systems to prevent material waste, paired with high-precision gating techniques (such as side gates, sub gates, or pinpoint gates) and optimized stripper plates or ejection pins for automated, deformation-free part demolding. Surface finishes can be meticulously refined to high polishing or flawless mirror surfaces depending on the clinical requirement.
Key Specifications
| Parameter | Specification Details (100% Customizable) |
| Molding Method | Liquid Silicone Rubber (LSR) Injection Molding |
| Part Material | Medical Grade LSR / Platinum-Cured Silicone (FDA, RoHS, REACH compliant) |
| Mold Steel Material | LKM, S136H, P20, 718H (High Wear Resistance) |
| Gate Type | Side Gate, Sub Gate, Direct Gate, Hook Gate, Pin Point Gate |
| Ejection Type | Stripper Plate, Ejection Pin, Air Ejection |
| Runner System | Cold Runner / Hot Runner Systems |
| Mould Life | 1,000,000 to 3,000,000 shots |
| Surface Treatment | High Polishing, Mirror Surface, VDI Texture |
| Cavity Count | Single or Multi-cavity (Optimized based on client production volume) |
| Maximum Mold Size | Up to 600mm x 600mm x 600mm |
Key Features & Advantages
- Premium Biocompatibility: 100% medical-grade liquid silicone rubber, hypoallergenic, BPA-free, odorless, and fully compliant with FDA regulations for direct skin and mucosal contact.
- Extreme Durability & Flexibility: Retains high tear strength and tensile flexibility under repeated sterilization cycles (autoclaving, gamma radiation, or ETO).
- High Precision & Complex Geometries: Advanced tool engineering allows for thin wall structures, undercut geometries, and sharp micro-markings (e.g., volume scales on menstrual cups).
- End-to-End OEM/ODM Customization: Fully tailored formulations (hardness ranging from 10 to 80 Shore A), custom translucent or opaque color matching, and customer brand logo engraving.
- Excellent Wear Resistance: High-grade mold steels ensure consistent part quality and absolute minimum flash throughout millions of production cycles.
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Custom Medical Grade Liquid Silicone Rubber (LSR) Components
Learn More →Technical B2B FAQ
Q1: What materials do you use for medical-grade silicone parts?
A: We exclusively source certified platinum-cured Liquid Silicone Rubber (LSR) from global leading manufacturers. These materials pass strict FDA, RoHS, and REACH criteria, ensuring absolute purity and biosafety.
Q2: Can we customize the hardness and color of our LSR products?
A: Yes. We can modify the shore hardness from 10A to 80A according to your application requirements (e.g., softer for nipple shields, firmer for dental trays). Colors can be matched precisely based on Pantone codes or sample chips.
Q3: What is the typical lead time for tool manufacturing and sample approval?
A: Generally, high-precision LSR mold design and fabrication take 25 to 35 days depending on part complexity and cavity count. Initial T1 samples are supplied immediately for customer evaluation and functional testing.
Q4: How does Sunmy Hardware ensure quality control for B2B bulk orders?
A: We enforce strict QC protocols, including incoming material inspection, automated injection process monitoring, 100% visual inspection for flash and contamination, and rigorous dimensional inspection using advanced CMM and optical projectors.
Q5: Do you support cleanroom manufacturing for medical LSR components?
A: Yes, we provide cleanroom-compatible production configurations to satisfy the strict hygiene and contamination-free requirements of critical medical, oral, and maternal care products.
Q6: What file formats are required for the initial DFM review?
A: We accept standard 2D and 3D CAD files, including STEP, IGES, SolidWorks (.sldprt), and PDF formats. Our engineering team will review these for draft angles, wall thickness, and gating locations.
Get a Fast, Technical Quote & Free DFM Review
Don't let tolerance stack-up delay your product launch. Submit your project details, and our engineering team will evaluate your design for manufacturability before the first cut.
