Overview:
Custom Medical Grade PVC Throat Tube Parts for Emergency Surgery are precision-engineered, single-use or reusable components designed for critical airway management and surgical procedures. Manufactured from biocompatible, non-toxic medical-grade PVC compliant with USP Class VI and ISO 13485 standards, these tubes offer exceptional flexibility, kink-resistance, and clarity for visual monitoring. Utilizing high-precision injection molding and advanced extrusion techniques, each component is produced under cleanroom conditions to ensure sterility, dimensional accuracy, and reliable performance in high-stakes medical environments. Our factory specializes in end-to-end OEM solutions—from design-for-manufacturability (DFM) and rapid prototyping to sterile packaging—enabling tailored tube configurations, connector compatibility, and radiopaque stripe options. Ideal for emergency intubation, suction, and surgical drainage applications, our throat tube parts enhance procedural safety and efficiency while reducing cross-contamination risks.
Features:
| Attribute | Details |
|---|---|
| Place of Origin | Xiamen, China |
| Brand Name | OEM |
| Material | Medical Grade PVC (USP Class VI, ISO 10993 compliant) |
| Size Range | ID 2.0–12.0 mm, OD 4.0–16.0 mm (custom sizes available) |
| Color | Transparent, with optional radiopaque stripes or color-coded sections |
| Sterilization | EtO, Gamma, or Steam (validated per AAMI/ISO 11135/11137) |
| Certification | ISO 13485, FDA, CE Mark, RoHS, REACH |
| OEM | Fully supported (custom lengths, connectors, packaging) |
| Sample Lead Time | 5–7 business days |
| Production Lead Time | 15–30 days (tooling-dependent) |
| MOQ | Pilot batches to high-volume orders |
Key Benefits:
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Biocompatible & Non-Toxic – Formulated without latex, DEHP, or heavy metals; suitable for short- and long-term patient contact.
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High Clarity & Kink-Resistance – Maintains lumen visibility and patency under bending or compression during emergency procedures.
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Rapid Prototyping & Customization – Adjustable durometer (soft to semi-rigid), tapered/beveled tips, and connector integration available.
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Sterile-Ready Packaging – Peelable pouches or Tyvek® packaging with batch-level traceability and UDI support.
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Consistent Performance – Smooth inner bore minimizes fluid retention; uniform wall thickness ensures predictable flexural behavior.
Manufacturing Process & Surface Treatment Options:
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Medical PVC Extrusion – Precision multi-layer extrusion with tight OD/ID tolerance control (±0.05 mm) and smooth surface finish.
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Injection Molding of Connectors/Fittings – Overmolding of PVC or polycarbonate connectors, luer locks, or flanges for leak-free assembly.
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Tip Forming & Drilling – Heat-based tip forming for atraumatic insertion; laser drilling for side ports or ventilation holes.
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Radiopaque Strip Co-extrusion – Integrated barium sulfate or bismuth subcarbonate stripes for X-ray visibility.
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Surface Smoothing & Deburring – Automated cutting and electropolishing of edges to prevent tissue irritation.
Quality Assurance:
Our quality management system—certified to ISO 13485—ensures that every Medical Grade PVC Throat Tube Part meets rigorous medical device standards. We perform:
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Raw Material Validation – FTIR analysis and certificate of compliance for each PVC resin batch.
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Dimensional & Visual Inspection – 3D optical measurement for inner/outer diameter, wall concentricity, and length; 100% visual check for bubbles, defects, or contaminants.
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Functional Testing – Flow rate validation, kink resistance under flexion, leakage tests at rated pressure, and connector pull-off force verification.
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Biocompatibility & Sterilization Validation – Extracts testing per ISO 10993-5 (cytotoxicity) and -10 (irritation); sterilization validation reports provided per ISO 11135/11137.
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Lot Traceability & Documentation – Full DHR (Device History Record) and certification for each production batch.
Our Factory:
Our medical device manufacturing facility operates Class 8 cleanrooms, equipped with dedicated PVC extrusion lines, multi-cavity injection molding machines (30–280 tons), and automated tip-forming stations. Advanced tooling—supported by CNC, mirror EDM, and laser-etching systems—ensures high-precision mold fabrication and rapid design iterations. In-process inspection instruments include laser micrometers, burst testers, tensile testers, and optical coordinate measuring systems. With in-house sterile packaging, labeling, and ethylene oxide (EtO) sterilization capabilities, we deliver end-to-end, regulatory-ready solutions for global emergency medical device markets.
