The Disposable Silicone Laryngeal Mask is a premium airway management device engineered for safe and comfortable establishment of a patent airway during general anesthesia, emergency resuscitation, and short-term respiratory support. Crafted from medical-grade liquid silicone-renowned for its superior softness, biocompatibility, and hypoallergenic properties-it features an anatomically contoured inflatable cuff that conforms seamlessly to the laryngeal inlet, creating a reliable leak-proof seal. Unlike PVC alternatives, the silicone material minimizes mucosal irritation and pressure injury, making it ideal for patients with sensitive airways or prolonged use (up to 24 hours). Designed for single-use sterility, it eliminates cross-infection risks and enables rapid airway deployment, serving as a cornerstone tool in operating rooms, emergency departments, ICUs, ambulatory clinics, and pre-hospital rescue scenarios.
The device's ergonomic design mimics human laryngeal anatomy: a flexible silicone airway tube connects to a soft, pliable cuff, ensuring atraumatic insertion without the need for a laryngoscope. The inflatable cuff, when filled with the provided syringe, expands evenly to form a tight seal around the laryngeal opening, isolating the airway from the esophagus to prevent aspiration of gastric contents. Clear depth markings on the airway tube guide precise positioning, while the integrated one-way inflation valve with pressure relief function prevents over-inflation (optimal cuff pressure: 20-25 cmH₂O), safeguarding mucosal blood flow. The 15mm ISO standard connector ensures universal compatibility with ventilators, anesthesia machines, and resuscitation bags. Each unit is pre-sterilized via EO gas, ready for immediate use with no complex assembly-critical for time-sensitive emergency situations. It complies with ISO 13485, CE, and NMPA medical device standards, undergoing rigorous quality validation to ensure structural integrity, sealing performance, and biocompatibility.
Product Specification
|
Item |
Description |
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Application |
Airway establishment during general anesthesia; emergency respiratory support for cardiac arrest/respiratory failure; short-term ventilation in ICUs/clinics; airway management during patient transfer; suitable for patients with PVC sensitivity |
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Core Components |
Anatomically contoured silicone inflatable cuff, flexible silicone airway tube, depth marking (cm), one-way inflation valve, pressure relief valve, 15mm ISO standard connector |
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Material |
Airway tube & cuff: Medical-grade liquid silicone; Inflation valve: Food-grade silicone; Connector: ABS (acrylonitrile-butadiene-styrene) |
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Compatible Populations |
Adults (Size 3-5), pediatric patients (Size 1.5-2.5), infants (Size 0.5-1) |
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Key Safety Features |
Anatomical cuff design (leak-proof seal), atraumatic silicone tip, depth marking, over-inflation protection valve, hypoallergenic silicone, single-use sterility |
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Dimensions |
Size 0.5 (Infant): Airway tube length 14cm, cuff diameter 2.4cm; Size 1 (Infant): Tube length 16cm, cuff diameter 2.8cm; Size 1.5 (Pediatric): Tube length 18cm, cuff diameter 3.2cm; Size 2 (Pediatric): Tube length 20cm, cuff diameter 3.6cm; Size 2.5 (Pediatric): Tube length 22cm, cuff diameter 4.0cm; Size 3 (Adult): Tube length 24cm, cuff diameter 4.8cm; Size 4 (Adult): Tube length 26cm, cuff diameter 5.2cm; Size 5 (Adult): Tube length 28cm, cuff diameter 5.8cm |
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Sterility |
EO-sterilized (single-use only, non-reusable) |
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Shelf Life |
3 years (unopened, properly stored in sterile packaging) |
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Accessory |
Sterile paper-plastic composite packaging, size-matched inflation syringe (5ml for Size 0.5-2.5; 10ml for Size 3-5), user instruction leaflet, cuff pressure reference chart |
Product Properties
- Superior Biocompatibility & Hypoallergenicity: Medical-grade liquid silicone meets ISO 10993 biocompatibility standards, with zero cytotoxicity, sensitization, or mucosal irritation. Ideal for patients with PVC allergies or sensitive airways, reducing the risk of adverse reactions during prolonged use.
- Atraumatic Airway Protection: Silicone's soft, pliable texture minimizes trauma to pharyngeal and laryngeal mucosa during insertion and cuff inflation. The rounded, smooth tip avoids tissue abrasion, making it safe for fragile pediatric/infant airways and long-term ventilated patients.
- Reliable Leak-Proof Seal: Anatomically contoured cuff adapts to individual laryngeal anatomy, achieving a tight seal at lower pressures (20-25 cmH₂O) with a leakage rate ≤3%-lower than PVC alternatives. Effectively prevents air leakage and aspiration, ensuring efficient ventilation.
- Easy & Rapid Deployment: Blind insertion in 10-30 seconds without laryngoscope or specialized training, enabling use by emergency physicians, paramedics, and non-anesthesiologist staff. Clear depth markings ensure accurate positioning, avoiding misplacement or over-insertion.
- Cross-Infection Prevention: Single-use, pre-sterilized design eliminates the need for reprocessing, blocking pathogen transmission between patients. EO sterilization ensures sterility with no residual toxins, complying with strict infection control protocols.
Application Scenarios
Operating Rooms: For general anesthesia in elective surgeries (orthopedics, gynecology, ophthalmology, plastic surgery) where tracheal intubation is unnecessary, enhancing patient comfort and reducing anesthesia-related airway complications.
Emergency Resuscitation: Emergency departments and pre-hospital teams for rapid airway management in cardiac arrest, respiratory failure, or trauma-induced airway obstruction, supporting CPR and ventilation.
ICUs & Critical Care: For short-term respiratory support in critically ill patients who cannot tolerate tracheal intubation, or as a backup airway during weaning from mechanical ventilation. Suitable for patients with PVC sensitivity or mucosal fragility.
Ambulatory Clinics: For minor procedures (dental extractions, dermatological surgeries, endoscopic examinations) requiring sedation and airway support, improving procedural safety and patient experience.
Pre-Hospital & Patient Transfer: Ambulances and inter-hospital transfer teams for maintaining airway patency during transportation of unstable patients, ensuring continuous ventilation in moving environments.
Pediatric & Neonatal Care: Size-specific designs for infants and children (Size 0.5-2.5) with small, delicate airways, providing gentle, atraumatic airway management in pediatric surgeries and neonatal resuscitation.
Physical Properties
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Item |
Specification |
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Operating Temperature |
-10℃~45℃ |
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Material Hardness |
Airway tube & cuff: Shore A 25-30 (softer than PVC alternatives); Silicone valve: Shore A 40-45 |
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Product Weight |
Size 0.5: 7g; Size 1: 9g; Size 1.5: 11g; Size 2: 14g; Size 2.5: 17g; Size 3: 21g; Size 4: 24g; Size 5: 27g |
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Airway Tube Inner Diameter |
Size 0.5: 1.8mm; Size 1: 2.2mm; Size 1.5: 2.6mm; Size 2: 3.0mm; Size 2.5: 3.4mm; Size 3: 4.0mm; Size 4: 4.5mm; Size 5: 5.0mm |
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Cuff Inflation Volume |
Size 0.5: 0.8ml; Size 1: 1.5ml; Size 1.5: 2.5ml; Size 2: 3.5ml; Size 2.5: 4.5ml; Size 3: 6.0ml; Size 4: 9.0ml; Size 5: 12.0ml |
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Seal Pressure Range |
20-25 cmH₂O (optimal for mucosal perfusion) |
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Leakage Rate |
≤3% (at 25 cmH₂O cuff pressure, 50 L/min airflow) |
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Tensile Strength |
≥18 N (airway tube, no breakage under axial tension) |
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Connector Compatibility |
15mm ISO standard (compatible with all ventilator/anesthesia circuit connectors) |
QA&QC
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 (25 cmH₂O) and airflow (50 L/min).
Cuff Inflation & Pressure Retention Test: Ensures the cuff maintains stable pressure for ≥24 hours without deflation; the one-way valve prevents air backflow.
Biocompatibility Assessment: Conducts cytotoxicity, skin sensitization, and mucosal irritation tests on silicone and contact materials, confirming compliance with ISO 10993.
Sterility Validation: 100% EO sterilization with biological indicator testing (Bacillus atrophaeus) 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, inflation, and ventilation cycles (≥100 cycles) to ensure no tube kinking, cuff rupture, or valve failure.
Physical Properties
|
Item |
Specification |
|
Operating Temperature |
-10℃~45℃ |
|
Material Hardness |
Airway tube & cuff: Shore A 25-30 (softer than PVC alternatives); Silicone valve: Shore A 40-45 |
|
Product Weight |
Size 0.5: 7g; Size 1: 9g; Size 1.5: 11g; Size 2: 14g; Size 2.5: 17g; Size 3: 21g; Size 4: 24g; Size 5: 27g |
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Airway Tube Inner Diameter |
Size 0.5: 1.8mm; Size 1: 2.2mm; Size 1.5: 2.6mm; Size 2: 3.0mm; Size 2.5: 3.4mm; Size 3: 4.0mm; Size 4: 4.5mm; Size 5: 5.0mm |
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Cuff Inflation Volume |
Size 0.5: 0.8ml; Size 1: 1.5ml; Size 1.5: 2.5ml; Size 2: 3.5ml; Size 2.5: 4.5ml; Size 3: 6.0ml; Size 4: 9.0ml; Size 5: 12.0ml |
|
Seal Pressure Range |
20-25 cmH₂O (optimal for mucosal perfusion) |
|
Leakage Rate |
≤3% (at 25 cmH₂O cuff pressure, 50 L/min airflow) |
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Tensile Strength |
≥18 N (airway tube, no breakage under axial tension) |
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Connector Compatibility |
15mm ISO standard (compatible with all ventilator/anesthesia circuit connectors) |
Reasons for choosing us
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.
Certificate
FAQ
Q:How long have you been producing this product?
A:We have been specializing in the production of this specific medical product for over 12 years. During this period, we have accumulated rich experience in process optimization, quality improvement, and regulatory compliance, and have served hundreds of customers worldwide with a proven track record of reliability.
Q:Do you support custom specifications or OEM/ODM?
A:Yes, we fully support custom specifications, OEM (Original Equipment Manufacturing), and ODM (Original Design Manufacturing) services. Our R&D and engineering teams can work with you to customize product dimensions, materials, functions, packaging, and labeling to meet your specific requirements. We also provide technical support throughout the customization process to ensure compliance with local regulations.
Q:What factors affect your pricing (volume, packaging, certifications)?
A:The key factors affecting our pricing include:
Order Volume: Larger order quantities qualify for higher volume discounts;
Customization Requirements: Specialized specifications, packaging, or labeling may incur additional costs;
Certifications: Products requiring additional regional certifications (beyond standard FDA/CE/ISO) may have slightly higher pricing due to certification costs;
Packaging Type: Premium packaging (e.g., sterile packaging, specialized tender packaging) or small-batch retail packaging may affect pricing;
Lead Time: Urgent orders requiring expedited production or shipping may involve additional fees.
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