The domestic medical dressing sector continues to innovate; many topical medical products no longer focus solely on basic protection but also place greater emphasis on the long-term safety of the substrate during continuous application and its adaptability to movement. Our newly mass-produced medical-grade TPU film is now available for industry supply. Backed by the dual certifications of the ISO 13485 medical device system and OEKO‑TEX safety certification, it provides upstream film material support for medical electrode sheets, wound protection dressings, fixation patches, and other products.
Unlike conventional industrial TPU films, this medical-grade film uses a specialized medical substrate as its raw material and contains no plasticizers in its formulation, thereby minimizing the risk of leaching. The material offers high toughness and stable rebound, excellent waterproof performance, and resists hardening or brittleness even at low temperatures. Its flexible surface allows it to conform to the expansion and contraction of the skin when applied to frequently moving areas such as joints, reducing the tendency for edges to lift or peel off and alleviating the restrictive sensation caused by the application.
The moisture permeability of the membrane material has been specifically calibrated to provide water resistance without allowing vapor transmission. External liquids and pathogens find it difficult to penetrate the membrane layer, thereby establishing a protective barrier over the wound; meanwhile, the moisture generated by the skin can be released outward, reducing the risk of dampness-induced maceration. This makes the material suitable for nursing products that require continuous application over multiple days. The material is compatible with ethylene oxide and radiation sterilization; its performance does not degrade after sterilization, meeting the regulatory requirements for the compliant marketing of medical devices.
The factory has established a comprehensive quality control process in accordance with the ISO 13485 system: raw materials undergo testing upon entry, production takes place in a cleanroom, in-process inspections are conducted, and finished products are sampled and tested; samples are retained and archived for each batch to minimize batch-to-batch variability. OEKO‑TEX testing confirms that the products contain no heavy metals or allergenic substances, are gentle on skin contact, and are suitable for maternal and infant care products as well as high-end medical applications.
Thickness, elasticity, breathability grade, and surface finish can be customized according to project requirements. Our products include wound dressings, waterproof fixation patches, physiotherapy electrodes, rehabilitation fixation accessories, and wearable sensing components. LEO New Materials will continue to optimize its formulations and manufacturing processes, consistently deliver high-quality medical membrane materials, and work with downstream partners to develop even higher-quality medical care products.
