Custom Medical Grade PVC Tube for Anesthesia and Intensive Care Application Manufacturer

Overview:

Our factory’s medical-grade PVC tubing designed for anesthesia delivery, respiratory systems, and intensive care applications. Our tubing is crafted from premium, phthalate-free PVC compounds enhanced with non-toxic stabilizers and plasticizers, ensuring biocompatibility, flexibility, and resistance to kinking or cracking. Produced via precision extrusion and sterilized using gamma irradiation or ETO methods, our products meet ISO 13485, FDA standards for medical device safety. We offer full OEM customization (sizes, colors, hardness) and one-stop service—from material selection and prototyping to bulk production and global logistics—to streamline your supply chain. Trust our expertise to deliver reliable, compliant tubing solutions tailored to critical healthcare environments.

Features:

Benefits of Our Products:

• Airway Maintenance & Mechanical Ventilation Compatibility
• Phthalate-Free PVC with Bonded Silicone Elastomer Coating
• Low-Friction, Non-Adherent Surface for Reduced Tissue Trauma
• Biocompatible, Low-Pressure High-Volume Cuff Sealing

 Quality Assurance:

Our QA framework ensures compliance with ISO 13485, FDA 21 CFR, and CE-MDR standards, prioritizing biocompatibility and patient safety. Rigorous material testing includes FTIR spectroscopy (for polymer purity) and GC-MS analysis (phthalate-free validation). Production involves automated extrusion with inline laser measurement for dimensional accuracy (ID ±0.1mm, wall thickness ±5%). Critical performance tests include burst pressure (up to 5x rated pressure), tensile strength (ASTM D638), and cytotoxicity (ISO 10993-5). Sterilization is validated via gamma irradiation/ETO with residual testing. All batches undergo 100% visual inspection and AQL sampling. Third-party certifications (RoHS, USP Class VI) and traceable lot documentation guarantee reliability for anesthesia and intensive care applications.  

Why Choose Us?

1. Industry Expertise:With over two decades of experience in silicone manufacturing, we specialize in producing high-quality, precision-engineered silicone products tailored to your exact requirements.
2. Custom Solutions:We provide comprehensive OEM services, offering full flexibility to customize logos, designs, and specifications to align seamlessly with your brand’s vision.
3. Dedicated Support:Our experienced team delivers personalized, one-on-one assistance, ensuring a smooth and efficient process from initial design to final delivery.
4. Unwavering Quality:With a rigorous quality control system in place, we uphold the highest industry standards, earning a strong reputation for reliability, consistency, and excellence.

 Our Factory:

Our state-of-the-art manufacturing facility is outfitted with the latest technologies, including CNC machining, Mirror EDM, EDM, and Slow-Speed Wire Cutting (WC), ensuring unparalleled precision in mold fabrication. We operate a robust fleet of 15 rubber compression molding machines and 2 LSR injection molding machines, maximizing both production output and operational efficiency.

To uphold the highest quality standards, we employ advanced tools such as 3D projectors, sealing testers, durometers, and elasticity measurement devices, all overseen by our expert quality control team. Our processes comply with ISO 9001 and IATF 16949 certifications, ensuring consistent, reliable results.

Additionally, we integrate automated systems like AutoDryers, high-speed doming machines, and die-cutting equipment to further streamline production, enhancing both accuracy and efficiency. This commitment to cutting-edge technology guarantees the delivery of superior products with exceptional performance.