Custom High Standard Medical-Grade Silicone Stomach Tube Suppliers

Overview:

Custom High Standard Medical-Grade Silicone Stomach Tube is a precision-crafted medical device designed for enteral feeding, drainage, or decompression. Manufactured using premium platinum-cured silicone, it ensures biocompatibility, flexibility, and durability. Advanced extrusion molding and vulcanization processes guarantee smooth surfaces, kink resistance, and sterilization readiness (autoclavable/ETO). Our FDA-compliant factory specializes in OEM solutions and one-stop services—from custom design, prototyping, and mass production to packaging—tailored to meet clinical or veterinary needs. Rigorous quality control ensures compliance with ISO 13485 standards. Partner with us for reliable, patient-safe silicone stomach tubes optimized for performance and cost efficiency.

Characteristics:

Benefits of Our Medical Grade Silicone Tube:

1. Crafted from 100% medical-grade silicone, offering clarity and flexibility.
2. Precisely finished side eyes and closed distal end minimize irritation to the esophageal mucosa.
3. Equipped with a radiopaque line along its length for enhanced X-ray visibility.
4. Designed with optimal hardness for kink resistance, featuring a smooth, non-toxic, and non-irritating surface with scale markings and an X-ray development line.

Quality Assurance:

Quality control for Custom High Standard Medical-Grade Silicone Stomach Tubes encompasses a comprehensive process to ensure safety, performance, and compliance with industry standards. Initially, all materials are inspected for conformity to FDA regulations and ISO 13485 certification for medical devices. During the molding process, advanced Liquid Silicone Rubber (LSR) injection molding machines are used to guarantee dimensional accuracy and uniformity. The finished tubes undergo thorough dimensional checks, visual inspections for defects, and biocompatibility testing in accordance with ISO 10993 standards. Additionally, they are subjected to rigorous leak and pressure testing to ensure reliability under medical conditions. Sterilization validation is performed using methods like ethylene oxide (EO) or gamma sterilization to ensure sterility. Cutting-edge testing equipment, including Melt Flow Index (MFI) testers, tensile testing machines, and X-ray inspection systems, supports these processes. Our manufacturing facility is ISO 13485 certified, ensuring consistent compliance with Good Manufacturing Practices (GMP) and international medical device quality standards. This rigorous approach guarantees that every silicone stomach tube is safe, durable, and fit for medical use.

Factory Show:

Our advanced manufacturing facility features cutting-edge technologies, including CNC machining, Mirror EDM, conventional EDM, and high-precision wire cutting, ensuring exceptional mold accuracy and repeatability. With 15 rubber compression molding machines and 2 LSR injection molding systems, we support high-volume production with unmatched speed and efficiency.

Certified to ISO 9001 and IATF 16949 standards, our facility maintains the highest quality through a comprehensive quality management system. Our inspection capabilities include 3D optical projectors, sealing integrity testers, durometers, and elasticity meters, all managed by a skilled quality assurance team.

Additionally, our Class 8 cleanroom and automated technologies, such as AutoDryers, high-speed doming equipment, and precision die-cutting machines, optimize operational efficiency and ensure product consistency. This streamlined approach enables us to deliver high-performance, precision-engineered components that meet the rigorous demands of today’s industries.