As the medical consumables industry continues to evolve toward greater standardization and higher quality, the safety and practicality of medical contact substrates have become core industry standards. Recently, our companys self-developed and mass-produced medical-grade TPU film was officially launched on the market. Leveraging its stable performance advantages and dual authoritative ISO 13485 and OEKO-TEX certifications, it provides compliant, high-quality substrates for medical products such as dressings, fixation patches, and monitoring patches.
This medical-grade TPU film is manufactured from high-purity medical-grade raw materials and contains no plasticizers. It exhibits an extremely low level of harmful substance leaching and offers advantages such as high elasticity, tear resistance, water resistance with breathability, and low-temperature resistance. The film surface is soft and skin-friendly, allowing free stretching in areas of body movement and minimizing edge curling or tightness, thereby significantly enhancing comfort during prolonged application.
The product offers scientifically balanced moisture permeability: it not only blocks external moisture and bacteria, protecting the wound from infection, but also promptly removes moisture from the skin, thereby reducing issues such as stuffy sweating, whitening, and maceration; it is therefore suitable for long-term dressing applications. Additionally, the material is compatible with mainstream sterilization methods, including ethylene oxide and irradiation; its performance remains stable and unchanged after sterilization, meeting the production standards for medical devices.
The entire production process strictly adheres to the ISO 13485 medical quality management system. From raw-material screening and dust-free production to process inspections, finished-product testing, and batch sample retention for traceability, the system implements closed-loop control throughout the entire process, ensuring consistent and stable quality for every batch. The products have passed OEKO‑TEX environmental testing and contain no heavy metals or allergenic substances; they can therefore be used directly on the skin and are suitable for high-end medical and maternal–infant healthcare products.
The product supports personalized customization; its thickness, hardness, breathability parameters, and appearance can all be adjusted as required. It is widely used in wound dressings, waterproof fixation patches, electrode patches, rehabilitation consumables, and wearable medical devices, among other applications. Going forward, the company will continue to optimize its process formulations, deepen its expertise in the field of medical new materials, and consistently provide highly compliant and highly stable medical substrates.
