Overview:
Custom Plastic Injection Mould Medical-Grade LSR Mold Tooling for Respiratory Mask Seals is precision-engineered tooling designed for manufacturing high-performance silicone seals used in respiratory therapy devices. The process involves high-precision CNC machining, EDM (electrical discharge machining), and rigorous surface finishing to ensure micron-level accuracy and airtight sealing properties. Molds are crafted from premium-grade tool steels (e.g., hardened H13 or stainless steel) paired with medical-grade liquid silicone rubber (LSR), which meets ISO 10993 biocompatibility standards for prolonged skin contact. Our factory specializes in custom design-to-production solutions, offering one-stop service from prototyping to mass production, including mold validation, material selection, and post-processing—ensuring fast turnaround, compliance, and seamless scalability for critical medical applications.
Features:
| Specification | Details |
| Raw Materials | ABS, PP, PC, PA66+30GF, PVC, POM, TPE, TPV, ASA, etc. |
| Die Steel | P20, P20HH, H13, 420, 2344, 2311 |
| Runner | Hot Runner / Cold Runner |
| Trademark | Customized |
| Design Software | AutoCAD, UG, Pro/E |
| Certification | TS16949, ISO 9001, ISO 13485 |
| Transport Package | Wooden Box or Carton Box |
| Production Capacity | 500 sets/year molds |
| Color | Customizable |
| MOQ | Small orders accepted |
| Place of Origin | Xiamen, China |
Surface Treatment Options:
- Polishing: Smooths and refines surfaces using progressively finer abrasives to reduce scratches and improve tactile feel.
- Mirror Polishing: Delivers a highly reflective, glass-like finish by employing ultra-fine abrasives and buffing compounds.
- Sand Blasting: Propels abrasive media at high velocity to uniformly clean, texture, or prep surfaces for subsequent coatings.
- Painting: Applies durable liquid or powder coatings to enhance corrosion resistance, aesthetics, and wear protection.
Benefits of Our Mold:
-
Ultra-Precision Machining (CNC/EDM):
Advanced CNC milling and electrical discharge machining (EDM) ensure micron-level cavity accuracy, critical for seamless, leak-free seals that meet strict medical airtightness requirements.
-
Validated Biocompatibility & Compliance:
Tooling is rigorously tested under FDA/ISO 13485 protocols, with material traceability for medical-grade LSR (ISO 10993 certified), guaranteeing safety for prolonged skin contact in respiratory therapies.
-
Optimized Cycle Efficiency with Cold Runner Systems:
Custom-designed cold runner molds minimize material waste, reduce curing time, and enable high-volume production scalability—ideal for fast-turnaround medical device orders.
-
Durable Tool Steel Construction (H13/Stainless Steel):
High-hardness tool steels resist wear and corrosion, extending mold lifespan even under frequent sterilization (e.g., autoclaving), lowering long-term per-part costs for OEMs.
Factory Show:
Our facility combines advanced CNC machining centers, mirror and conventional EDM, and high-precision wire-cutting to achieve unparalleled mold accuracy and repeatability. With 15 rubber compression presses and 2 state-of-the-art LSR injection machines, we seamlessly manage both high-volume production and bespoke tooling projects. Rigorous QA—driven by seasoned specialists and ISO 9001/IATF 16949 certification—is enforced via 3D projectors, seal-integrity testers, durometers, and elasticity gauges. Integrated automation (AutoDryers, high-speed doming, precision die-cutting) further optimizes throughput and consistency, delivering performance-critical components that meet the strictest industry requirements.
