ROA Medicare
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We manufacture high-quality medical silicone respiratory masks and components, including oxygen masks, anesthesia masks, and customized silicone parts for respiratory systems.
All products are produced in an ISO 13485 certified cleanroom using FDA & LFGB compliant materials, ensuring consistent performance and medical-grade safety.
From prototyping to mass production, we provide professional OEM silicone solutions trusted by global healthcare brands.
| Category | Specification | Standard / Value | Remarks |
|---|---|---|---|
| Material | Medical Grade LSR | Platinum-Cured | USP Class VI, ISO 10993, FDA Compliant |
| Quality System | ISO 13485:2016 | Certified | Full traceability for medical devices |
| Hardness | Shore A | 10 A to 80 A | Customizable for soft seals or rigid parts |
| Tensile Strength | ≥ 8 MPa | Durability | High tear resistance |
| Temp Resistance | -50°C to +200°C | Broad Range | Suitable for autoclaving & sterilization |
| Biocompatibility | Certified | Non-toxic | Long-term skin and fluid contact safe |
Established in 2007, we are a high-tech manufacturer focused on custom silicone processing. With modern facilities spanning over 3000 square meters, we specialize in LSR injection molding and HTV molding.
Our expertise includes advanced one-piece molding technologies such as silicone-to-metal overmolding, silicone-to-plastic, and silicone-to-glass solutions, ensuring high-quality results for medical, baby, and industrial applications.
