Medical device specialty masterbatch
MEDICAL MASTERBATCH
Medical products must not"trading decoration for safety"—Color here is a verifiable performance metric, not an appearance parameter.
Four core capabilities
Biocompatibility compliance
Carriers and pigments are evaluated under the ISO 10993 system, meeting cytotoxicity, sensitization and intracutaneous reaction requirements, and can be used directly for parts in contact with the human body.
Sterilization-resistant without yellowing
After EO,γ Irradiation (25–50 kGy) and 121–Color difference after 134 °C high-pressure steam sterilization ΔE ≤ 0.5, no yellowing, no migration.
Ultra-low plate-out, high purity
Yes. We offer OEM/ODM services with custom formulations and private label options, backed by our dual-laboratory R&D and 9 twin-screw extrusion lines.
Full batch traceability
Manufactured under the ISO 13485 system; formulation and process changes are controlled and revalidated; each batch comes with a COA; customer audits and full traceability are supported.
Key specs KEY SPECS
Typical applications APPLICATIONS
With nearly 30 years in the plastics industry, Colour Plastic has been honored as one of China Plastics City's Top Ten Modified Plastics Enterprises, a Contract-Honoring & Credit-Keeping enterprise, and a Zhejiang Science and Technology SME.