Overview:
Medical Grade PVC Tubing is a highly flexible and durable solution designed for healthcare applications. Made from high-purity PVC free of phthalates and harmful additives, it is produced through precision extrusion to ensure consistent wall thickness and smooth surfaces. Our tubing is FDA-approved, ISO 13485-certified, and meets USP Class VI standards, ensuring safe and reliable performance for fluid transfer, IV lines, and respiratory systems.
Key benefits include superior chemical resistance, kink resistance, and optical clarity for easy monitoring. We also offer custom solutions with tailored sizes, lengths, and sterilization compatibility (autoclave, EO, gamma) to meet specific clinical requirements.Our Medical Grade PVC Tubing is engineered for optimal performance and compliance, ensuring the highest standards of patient care.
Features:
- Material: Medical Grade PVC
- Place of Origin: Xiamen, China
- Brand Name: OEM Brand
- Size: Custom
- Color: Custom
- Quality Certification: ISO 9001, FDA
- OEM: Yes
- Usage: Feeding food for patients
- MOQ: According to your requirement
- Sample: Custom
Benefits of PVC Tubing:
- Medical-Grade Quality
Manufactured from FDA-approved, medical-grade PVC, ensuring compliance with rigorous healthcare standards and providing a safe solution for patient care.
- Precision Engineering
Produced to exact specifications, ensuring a perfect fit for medical equipment and seamless integration with hospital systems.
- Smooth, Burr-Free Edges
Designed with flawless, smooth edges to eliminate sharpness, enhancing both safety and comfort for medical staff and patients.
- Tailored Customization
Available in a variety of sizes and colors to meet specific hospital needs, offering flexibility for diverse medical applications and patient requirements.
Production Process:
- Material Selection
The process begins with sourcing high-quality, FDA-approved, medical-grade PVC material, ensuring it meets stringent healthcare standards for safety and performance.
- Compounding
The PVC material is mixed with specific additives to achieve desired properties, such as flexibility, durability, and biocompatibility, ensuring it’s suitable for medical applications.
- Extrusion
The compounded PVC is heated and extruded into tube form using a high-precision extrusion machine, maintaining consistent wall thickness and dimensions throughout the length of the tube.
- Custom Sizing and Shaping
The tube is cut to custom lengths and shaped to meet the specific needs of the medical equipment it will be integrated into. This step includes adjustments for diameters and wall thicknesses.
- Burr Removal & Surface Finishing
Once extruded, the tubing undergoes a thorough deburring process to remove any sharp edges. The surface is polished to ensure smoothness, enhancing both safety and comfort.
- Sterilization
The tubes are sterilized using methods such as gamma radiation or ethylene oxide to ensure they are free from contaminants and safe for direct contact with patients.
- Quality Control & Testing
Each batch of tubing is carefully inspected for quality, with tests performed to check for dimensional accuracy, tensile strength, and flexibility. Only tubes that pass these rigorous checks are approved for medical use.
- Packaging & Shipping
Finally, the finished PVC tubes are carefully packaged in sterile conditions, ready for shipment to healthcare facilities, ensuring they arrive in optimal condition for use.
Quality Assurance:
Our Quality Assurance process for Medical-Grade PVC Tubing involves strict adherence to industry certifications, including FDA approval, ISO 13485, and USP Class VI standards. The process includes comprehensive testing using advanced technology to ensure every tube meets the highest safety and performance criteria.
– Tensile Strength Testing: Utilizing tensile testers to validate the tubing’s strength and durability under pressure.
– Material Purity Analysis: FTIR spectrometers are employed to assess the purity of the PVC material, ensuring it meets medical-grade specifications.
– Sterilization Compatibility: The tubing is tested in autoclaves to confirm it can withstand sterilization processes commonly used in medical environments.
– Dimensional Accuracy: Laser micrometers ensure precise dimensional consistency, providing reliable fit and performance.
– Biocompatibility & Chemical Resistance: Cytotoxicity and extractables testing verify that the tubing is safe for contact with biological tissues and resistant to chemical degradation.
– Comprehensive Testing: Our quality protocols also include batch traceability, particulate monitoring, and pressure/leak testing, ensuring the tubing’s integrity for demanding hospital applications.
This rigorous, end-to-end quality control process guarantees that our medical-grade PVC tubing adheres to global medical standards, reducing risks in critical applications such as IV therapy, dialysis, and ventilation systems.
Our Factory:
We operate a comprehensive range of plants and equipment to ensure the highest quality production. Our mold-making facilities are equipped with advanced CNC machines, Mirror EDM, EDM, Slow-speed Wire Cut WC, and other auxiliary equipment.
In addition, our production lines are outfitted with 15 sets of rubber compression machines and 2 sets of LSR injection machines. To maintain superior quality standards, we utilize 3D projectors, sealing testers, elasticity measurement tools, durometers, and a qualified QC team.
Our mechanical equipment includes an AutoDryer Line, automatic screen printing machines, 3D measuring instruments, automatic high-speed doming machines, die-cutting machines, automatic die-cutting machines, CNC machines, and more.
This combination of professional and automated production lines, advanced mechanical equipment, and rigorous quality control measures is further supported by our Class 8 cleanroom, ensuring that we deliver products of the highest standard in a controlled, contaminant-free environment.
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