One time Use Sterile Silicone Laryngeal Mask Airway CE ISO Medical Grade Safe

Product Specification

Our CE ISO Medical Sterile Silicone Laryngeal Mask Airway (LMA) is a premium single-use supraglottic airway device designed to establish a clear and secure airway during anesthetic procedures or emergency situations. Manufactured from high-quality medical-grade silicone and backed by stringent CE and ISO certifications, this device ensures patient safety, clinical reliability, and optimal airway management. As a sterile, single-use product, it eliminates the risk of cross-contamination while providing consistent performance for healthcare professionals.

Key Features & Benefits:

• Premium Medical-Grade Silicone: Constructed from soft, biocompatible, and latex-free silicone. The material is gentle on mucosal tissues, reducing the risk of post-operative sore throat and airway trauma while ensuring patient comfort.

• CE & ISO Certified: Manufactured in strict compliance with international quality and safety standards (CE and ISO 13485). These certifications guarantee product sterility, biological safety, and consistent manufacturing quality for clinical use.

• Sterile and Single-Use: Individually packaged and sterile, this device is intended for single-patient use only. It effectively eliminates the risk of cross-infection and hospital-acquired infections associated with reusable devices.

• Anatomically Shaped Cuff: Features a precisely designed, inflatable cuff that creates a low-pressure seal around the glottis. This design ensures effective ventilation at lower cuff pressures, minimizing compression trauma to surrounding pharyngeal structures.

• Integrated Bite Block: The airway tube includes a built-in bite block to prevent the patient from occluding the airway, enhancing safety during emergence from anesthesia.

• Smooth and Kink-Resistant Airway Tube: The flexible tube is reinforced to prevent kinking or collapsing, ensuring uninterrupted gas flow and easy connection to anesthesia circuits or resuscitation bags.

• Clear Depth Markings: The tube is printed with clear depth indicators to assist clinicians in achieving accurate placement depth, reducing the risk of malposition.

• Universal 15mm Connector: Features a standard 15mm connector that is compatible with all common anesthesia machines, ventilators, and manual resuscitation bags.

Indications & Target Patients:

The CE ISO Medical Sterile Silicone Laryngeal Mask Airway is suitable for a broad range of patients and clinical scenarios, including:

• Surgical Patients Undergoing General Anesthesia: Ideal for routine elective surgeries where tracheal intubation is not required, providing a less invasive alternative to endotracheal tubes.

• Emergency Airway Management: Used by first responders, emergency physicians, and critical care teams as a primary or rescue device in difficult airway situations.

• Patients Requiring Short-Term Ventilation: Suitable for procedures lasting from 30 minutes to several hours, offering stable airway control in both spontaneous and controlled ventilation modes.

• Pediatric to Adult Patients: Available in a complete range of sizes (from neonate to large adult) to accommodate patients of all ages and anatomical variations.

• Outpatient and Same-Day Surgery Centers: The single-use nature makes it ideal for high-turnover environments where infection control and efficiency are priorities.

• Patients at Risk of Cross-Contamination: Immunocompromised individuals or those with infectious diseases benefit significantly from the sterile, disposable design.