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Polypropylene Resin 5012XT - High Crystallinity Grade for Medical Device Molding
Product Spotlights
Medical-grade PP resin with high crystallinity for precision medical device molding. Offers superior chemical resistance, biocompatibility per ISO 10993/USP Class VI, and enhanced mechanical properties. Manufactured under ISO 13485 certified system with global shipping capabilities from China ports.
Negotiable
MOQ: 1 Kilogram (Price negotiable depending on order volume and customization)
Key Specifications
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Color:
Other, Natural (Customizable)
Material:
Polypropylene Copolymer
Application:
Medical Device Molding
Payment & Shipping
Payment Methods:
Port of Shipment:
SHANGHAI/NINGBO
Delivery Detail:
3 days
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Color
Other, Natural (Customizable)
Material
Polypropylene Copolymer
Application
Medical Device Molding
Certification
ISO 13485, ISO 9001, HACCP
Model
5012XT
Crystallinity
High
Processing Method
Injection Molding
Regulatory Compliance
Medical Grade
As a specialized manufacturer at Shanghai Wenqin Plastics Co., Ltd., we engineer the Polypropylene Resin 5012XT to meet rigorous medical industry standards. Established in 2020, our facility leverages advanced polymer technology to deliver materials that ensure precision and reliability in critical healthcare applications. This high-crystallinity grade resin provides exceptional structural integrity for medical components requiring uncompromised performance.
Key Technical Advantages:
- Enhanced Chemical Resistance: Withstands sterilization protocols including autoclaving and gamma irradiation
- Superior Mechanical Properties: High stiffness-to-impact ratio maintains dimensional stability
- Biocompatibility: Compliant with USP Class VI and ISO 10993 biological safety requirements
Technical Specifications:
| Property | Value | Test Method |
|---|---|---|
| Melt Flow Rate (230°C/2.16kg) | 12 g/10min | ASTM D1238 |
| Tensile Yield Strength | 34 MPa | ISO 527 |
| HDT @ 0.45 MPa | 132°C | ISO 75 |
Manufacturers benefit from reduced cycle times due to optimized crystallization kinetics, while the material's low moisture absorption (
- Surgical instrument housings
- Diagnostic device components
- Implantable device containers
- Laboratory equipment
Shanghai Wenqin Plastics maintains comprehensive certifications including ISO 13485 for medical device materials. With shipments available from Shanghai and Ningbo ports, we serve global markets across North America, Europe, and Asia-Pacific regions. Our 11-50 employee operation combines agile production with stringent quality systems to ensure batch-to-batch consistency for critical applications.
Frequently Asked Questions:
-
Q: Is this material suitable for long-term implantable devices?
A: While compliant with biocompatibility standards, specific device validation is recommended -
Q: What sterilization methods are compatible?
A: Validated for steam, ethylene oxide, and radiation sterilization protocols -
Q: Do you provide material certifications?
A: Certificates of Analysis and Compliance are available upon request -
Q: Can custom formulations be developed?
A: Customization options are available for specialized requirements -
Q: What is the minimum order quantity?
A: MOQ starts at 500kg with flexible packaging options -
Q: How do you ensure regulatory compliance?
A: Our QMS integrates FDA 21 CFR Part 820 requirements
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1Yr
Year Established
2020
Factory Size
Below 1,000 square meters
Total Employees
11 - 50 People
Product Certifications
HACCP, TL900, QS9000, SA8000, ISO9001, ISO9004, ISO17799, ISO9000, ISO14000, ISO10441, ISO16949, TS16969, ISO19011:2000, OHSAS18001, Others
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