Overview
Our Custom Medical Grade PVC Throat Tube for Surgical Emergency Application is engineered for reliable airway management in emergency and surgical settings. Manufactured from medical-grade, DEHP-free PVC and produced under ISO Class 7 cleanroom conditions, the tube delivers excellent kink-resistance, atraumatic tip geometry, and consistent dimensional accuracy. Designed for quick, secure insertion and dependable performance, the product supports cuffed and uncuffed options, radiopaque visibility, and integrated connector/overmold features for seamless compatibility with anesthesia and ventilation systems.
Basic Information
| Attribute | Details |
|---|---|
| Material | Medical-grade PVC (DEHP-free), optional polyurethane/TPU blends |
| Place of Origin | Xiamen, China |
| Brand | OEM / Custom Branding |
| Sizes | Wide range available (examples: ID 2.0–10.0 mm; length configurable) |
| Type | Cuffed / Uncuffed / Reinforced / Disposable |
| Surface | Smooth, low-friction lumen; atraumatic soft tip |
| Connector | Standard 15 mm or custom overmolded connector |
| Radiopacity | Optional embedded radiopaque strip |
| Tolerance | Typical ±0.02–0.10 mm (per spec) |
| Sterilization | EtO, Gamma (upon request) |
| Certifications | ISO 13485, ISO 9001; materials meet FDA & ISO 10993 biocompatibility requirements |
| MOQ / Samples | Small runs & samples available on request |
| Lead Time | Prototypes: 10–20 days; Production: configurable by qty |
Key Features & Benefits
- Precision extrusion and heat-forming produce uniform wall thickness and consistent inner diameters for predictable airflow and device fit.
- Atraumatic soft tip and smooth lumen minimize tissue irritation and reduce insertion resistance.
- Optional cuff design with validated cuff inflation performance and low-leak profile for secure ventilation.
- Radiopaque strip available for x-ray visibility and placement confirmation.
- Overmolded connector and color-coded sizing for rapid identification and secure interface with ventilators and masks.
- DEHP-free formulation and biocompatible materials suitable for single-use disposables and sterile applications.
Quality Assurance & Testing
We operate under ISO 13485 quality systems with full traceability and documented batch records. Product validation includes:
- Biocompatibility per ISO 10993 (cytotoxicity, sensitization, irritation).
- Dimensional verification with CMM and laser gauging.
- Burst pressure, tensile strength, and kink-resistance testing.
- Cuff leak and inflation/deflation cycle testing (for cuffed variants).
- Sterility validation and residuals testing for EtO/gamma sterilized lots.
- Functional flow testing and visual inspection with 100% final QC where required.
Why Partner With Us
- Medical Expertise — Years of experience supplying OEMs and healthcare providers with validated airway devices and sterile disposable solutions.
- Full Customization — Sizes, cuff options, connectors, radiopacity, color coding, and packaging tailored to your clinical requirements.
- Regulatory Support — Documentation packages available (DFU, device history records, biocompatibility reports) to support regulatory submissions and supplier audits.
- Scalable Capacity — Rapid prototyping to high-volume sterile production with controlled lead times and reliable logistics.
Factory & Capabilities
Our facility features precision extrusion lines, CNC mandrel tooling, automated laser cutting and end-forming stations, ultrasonic welding and overmolding capability, and class-controlled cleanroom assembly. We provide in-house sterilization coordination, validated packing (blister/peel pouch), and automated inspection systems to ensure consistent product quality and regulatory compliance.
