Polypropylene Copolymer M4500B Granules for Medical Devices With Sterilization Capability
Product Spotlights
Shanghai Wenqin Plastics Co., Ltd., established in 2020 and headquartered in Shanghai, China, proudly introduces our premium Polypropylene Copolymer M4500B Granules, specifically engineered for medical devices with sterilization capabilities. As a dedicated manufacturer with a compact factory under 1,000 square meters and a skilled team of 11-50 employees, we focus on delivering high-purity materials that meet rigorous industry standards. Our granules offer exceptional reliability and biocompatibility, ensuring they are ideal for critical healthcare applications where safety and performance are paramount. By leveraging advanced production techniques and strict quality controls, we provide cost-effective solutions that reduce manufacturing risks and enhance product longevity for global partners.
Key features and advantages:
Superior Sterilization Performance: The M4500B granules are designed to withstand common sterilization methods such as autoclave and ethylene oxide, making them perfect for reusable medical tools and implants without degradation.
High Purity and Safety: Manufactured under controlled environments, our material ensures low extractables and leachables, minimizing contamination risks in sensitive medical applications.
Enhanced Durability: With excellent chemical resistance and thermal stability, these granules maintain integrity under harsh conditions, extending the lifespan of medical devices.
Technical specifications include precise parameters that guarantee consistency and compliance. Below is a summary of core attributes:
| Parameter | Value | Benefit |
| Density | 0.905 g/cm³ | Lightweight for easy handling and reduced shipping costs |
| Melt Flow Index | 12 g/10 min | Optimized for injection molding precision |
| Tensile Strength | 35 MPa | Ensures robustness in medical components |
| Sterilization Compatibility | Autoclave, EtO, Gamma | Versatile for various healthcare protocols |
Clients benefit from reduced downtime and lower total cost of ownership due to the material's ease of processing and minimal waste. Additionally, our granules support customization in color and size to match specific device requirements, fostering innovation in medical design.
Backed by certifications such as ISO9001, ISO14000, and OHSAS18001, Shanghai Wenqin Plastics ensures every batch adheres to global quality and environmental standards. We ship primarily from Shanghai and Ningbo ports, serving diverse markets including North America, Europe, Asia, and beyond. This extensive reach, combined with our commitment to ethical practices, provides you with a dependable supply chain partner. Experience the reliability and innovation of M4500B granules—contact us today for samples or detailed quotes to elevate your medical device production.
Frequently Asked Questions:
Q: What sterilization methods are compatible with these granules?
A: Our granules are tested for compatibility with autoclave, ethylene oxide, and gamma radiation, ensuring safety in multiple medical settings.Q: Are custom formulations available for specific applications?
A: Yes, we offer customizable options for color, size, and additives to meet unique device requirements, subject to request.Q: What certifications support the quality of this product?
A: It holds ISO9001 for quality management, ISO14000 for environmental standards, and OHSAS18001 for occupational health, among others listed in our certifications.Q: How do I ensure biocompatibility for medical use?
A: The material undergoes rigorous testing to meet ISO 10993 standards for biocompatibility, making it suitable for implants and tools.Q: What is the typical lead time for orders?
A: Lead times vary based on order volume and customization; details are provided upon inquiry to ensure timely delivery.Q: Can these granules be used in FDA-regulated devices?
A: While designed for medical applications, specific FDA compliance depends on end-use; we provide documentation to support regulatory submissions.Q: How is packaging handled to maintain purity?
A: Granules are packed in sealed, contamination-free bags with optional moisture barriers to preserve integrity during transit.Q: What markets do you primarily serve?
A: We export globally, including North America, Europe, Asia, and more, with efficient logistics from Shanghai and Ningbo ports.
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