Disposable PVC Laryngeal Mask

The Disposable PVC Laryngeal Mask is a specialized airway management device designed for establishing and maintaining a patent airway during general anesthesia, emergency resuscitation, or short-term respiratory support. Crafted from medical-grade PVC, it features an anatomically contoured cuff that fits snugly over the laryngeal inlet, creating a reliable seal to facilitate mechanical ventilation or spontaneous breathing without tracheal intubation. With its intuitive insertion design, secure sealing performance, and single-use sterility, it eliminates cross-infection risks and reduces airway trauma, making it an essential tool in operating rooms, emergency departments, ICUs, and pre-hospital rescue scenarios.

Engineered to mimic human laryngeal anatomy, the device consists of a flexible airway tube connected to a soft, inflatable cuff. The smooth, atraumatic tip ensures easy insertion without the need for a laryngoscope, while the cuff-when inflated-forms a leak-proof seal around the laryngeal opening, isolating the airway from the esophagus to prevent aspiration. The airway tube is marked with depth indicators for precise positioning, and the integrated inflation valve allows controlled cuff pressure adjustment to avoid mucosal ischemia. Each unit is pre-sterilized and ready for immediate use, with no complex assembly required, enabling rapid airway establishment in critical situations. It complies with ISO 13485, CE, and NMPA medical device standards, undergoing rigorous quality testing to ensure structural integrity, sealing performance, and biocompatibility.

 

 

• Cross-Infection Prevention: Single-use, pre-sterilized design eliminates the risk of cross-contamination from repeated use and reprocessing, critical for infection control in healthcare settings.
• Anatomical Fit & Reliable Sealing: Contoured cuff adapts to the natural shape of the laryngeal inlet, ensuring a tight seal with minimal pressure (20-30 cmH₂O). Effectively prevents air leakage and aspiration of gastric contents, supporting effective ventilation with a leakage rate ≤5%.

 

 

 

• Easy & Rapid Insertion: No laryngoscope or specialized training required-can be inserted blindly in 10-30 seconds. Smooth tip and flexible tube reduce trauma to pharyngeal and laryngeal mucosa, suitable for emergency scenarios and non-anesthesiologist users (e.g., emergency physicians, paramedics).
• Precise Positioning: Clear depth markings (in cm) on the airway tube guide accurate insertion, avoiding over-insertion or misplacement. The 15mm standard connector is compatible with all ventilators, anesthesia machines, and resuscitation bags for seamless integration.
• Biocompatible & Hypoallergenic: Medical-grade PVC material meets ISO 10993 biocompatibility standards, with low cytotoxicity and no sensitization. Soft, non-irritating cuff minimizes mucosal damage even during prolonged use (up to 24 hours).

Certifications: Fully complies with ISO 13485 medical device quality management system standards, CE medical device certification, and NMPA registration requirements. Each production batch undergoes rigorous quality testing:

Seal Integrity Test: Verifies no air leakage under simulated clinical cuff pressure (30 cmH₂O) and airflow (50 L/min).

Cuff Inflation & Pressure Retention Test: Ensures the cuff maintains pressure for ≥24 hours without deflation, and the one-way valve prevents air backflow.

Biocompatibility Assessment: Conducts cytotoxicity, skin sensitization, and mucosal irritation tests on all patient-contact materials.

Sterility Validation: 100% EO sterilization with biological indicator testing to confirm no viable microorganisms.

Dimensional Accuracy Test: Validates airway tube length, cuff size, and depth marking precision (tolerance ±0.5mm/cm).

Structural Stability Test: Simulates insertion and ventilation cycles to ensure no tube kinking, cuff rupture, or valve failure.

Each product is marked with a unique batch number, size, and expiration date for full traceability of production, sterilization, and distribution. A detailed Instruction for Use (IFU) is provided, including insertion steps, cuff pressure guidelines, and contraindications.

Packing: Individual units are sealed in EO-sterilized paper-plastic composite packaging (waterproof, dustproof, and tear-resistant) with a sterile inflation syringe and user manual. Each package is labeled with product name, size, batch number, sterilization date, expiration date, and "Sterile" indicator. Bulk transport in sturdy corrugated cartons with anti-crush foam inserts to protect packaging integrity.

Storage: Store in a clean, dry, well-ventilated environment with a temperature of -10℃~40℃ and relative humidity ≤80%. Avoid direct sunlight, high temperature, high humidity, and contact with sharp objects or corrosive substances (e.g., acids, alkalis). Keep packages sealed until immediate use; do not use if the packaging is torn, damaged, or the sterile indicator shows invalidation. Stack cartons no more than 10 layers to prevent crushing.

Handling: Single-use only-discard immediately after use; do not reuse, reprocess, or sterilize to avoid cross-infection and material degradation. Inspect the package for damage and the product for defects (e.g., tube kinking, cuff damage) before use; do not use if any abnormalities are found. Avoid excessive force during insertion to prevent airway mucosal trauma.

Transportation: Transport in accordance with national and international medical device transportation regulations, avoiding violent collision, jolting, rain, or moisture. Use insulated vehicles for transportation in extreme temperature environments (below -10℃ or above 40℃) to ensure product integrity. The transportation process shall be recorded, including departure date, destination, transportation conditions, and receiver information, for full traceability.

Zhejiang Mediunion Healthcare Group Co. Ltd. (a branch of Evergrand Healthcare Group, founded in 2014) is located in Ningbo City, Zhejiang Province - enjoying an excellent location and convenient transportation. Our business covers medical device manufacturing & sales, plus investments in nursing homes, dental clinics, specialist hospitals and medical care services. Our products are sold worldwide, and we've won global consumer recognition with high-quality goods and comprehensive after-sales service.

Diversified Product Portfolio

Our product range includes disposable medical consumables, medical equipment and non-woven products (e.g. dental supplies, respiratory care items). This diverse lineup caters to the needs of medical institutions, clinics and other clients.

Reliable Supply & Collaboration

We have rich industry experience and partner with over 600 factories. These partners are equipped with advanced production equipment and skilled frontline staff, enabling us to produce customized products/components as per specific requests.

Strict Quality Assurance

We prioritize innovation & quality, backed by the ISO 13485:2016 quality management system. Strict control runs through raw material procurement, mass production, process management and finished product release. Our professional services (production control, order follow-up, delivery) also set us apart.

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