Certified Class II & Class III high-precision clinical consumables engineered in cleanroom facilities for international hospital tenders and GPO procurement.
As a leading China Top Laryngeal Mask Manufacturer & Exporter, our engineering paradigm is rooted in advancing supraglottic airway management through rigorous polymer science, anatomical precision, and clinical risk mitigation. The Laryngeal Mask Airway (LMA) has revolutionized modern anesthesia, emergency resuscitation, and difficult airway algorithms by establishing an airtight seal around the laryngeal inlet without requiring direct laryngoscopy or neuromuscular blockade.
From early first-generation classical PVC masks to contemporary third-generation reinforced medical-grade liquid silicone rubber (LSR) devices with gastric drainage channels, modern supraglottic devices must satisfy two mandatory clinical benchmarks: maximum airway seal pressure (to allow positive pressure ventilation) and minimal pharyngeal mucosal wall pressure (to prevent ischemia, hypoglossal nerve palsy, and post-operative sore throat).
Our comprehensive production facility integrates automated liquid silicone injection molding, high-precision extrusion, and ultrasonic bonding within Class 7 and Class 8 cleanrooms certified under ISO 13485. Every single-use and reusable laryngeal mask airway—spanning sizes from 1.0 (infants < 5 kg) up to 5.0 (large adults > 70 kg)—undergoes automated digital leak testing at 100% processing volume prior to sterilization.
Technical advancements engineered to eliminate micro-aspiration, anatomical displacement, and catheter-related bloodstream infections (CRBSI).
Integrated esophageal drain tube allows simultaneous gastric decompression and blind insertion of a 60° curved nasogastric tube, separating the respiratory tract from gastrointestinal secretions to drastically reduce regurgitation risk.
Hemodialysis catheter bodies feature advanced polyurethanes that remain firm during insertion for easy Seldinger wire tracking, but soften at 37°C vascular environment to protect delicate venous endothelial walls.
Engineered optical aperture bars embedded within the LMA mask bowl prevent epiglottic downfolding into the airway lumen, maintaining an uninhibited oxygenation path even under challenging intubation conditions.
Reinforced spiral wire tubing and pre-molded bite blocks safeguard airway patency against accidental teeth clenching during light anesthesia emergence, eliminating sudden ventilation drops.
Optional surface treatments for long-term central venous and hemodialysis catheters inhibit bacterial colonization (Staphylococcus epidermidis) and thrombus formation, supporting multi-month vascular access.
Standardized 15mm optical connector hubs molded from impact-resistant polycarbonate ensure leak-free attachment to all standard anesthesia machines, manual resuscitators, and ventilator circuits.
Comprehensive clinical specifications and sizing guidelines for pediatric, adult, and specialized surgical applications.
| Mask Size | Patient Weight Category | Max Cuff Inflation Vol. | Max Intracuff Pressure | Connector Size | Recommended Patient Profile |
|---|---|---|---|---|---|
| Size 1.0 | Neonates / Infants (< 5 kg) | Up to 4 mL | ≤ 60 cm H2O | 15 mm OD | Neonatal ICU, Pediatric Anesthesia |
| Size 1.5 | Infants (5 kg – 10 kg) | Up to 7 mL | ≤ 60 cm H2O | 15 mm OD | Infant Short Surgical Procedures |
| Size 2.0 | Infants / Children (10 kg – 20 kg) | Up to 10 mL | ≤ 60 cm H2O | 15 mm OD | Pediatric Outpatient Surgery |
| Size 2.5 | Children (20 kg – 30 kg) | Up to 14 mL | ≤ 60 cm H2O | 15 mm OD | Pediatric Specialty Procedures |
| Size 3.0 | Small Adults (30 kg – 50 kg) | Up to 20 mL | ≤ 60 cm H2O | 15 mm OD | Adolescent & Petite Adult Airway Management |
| Size 4.0 | Normal Adults (50 kg – 70 kg) | Up to 30 mL | ≤ 60 cm H2O | 15 mm OD | Standard Adult Elective & Emergency Surgery |
| Size 5.0 | Large Adults (70 kg – 100+ kg) | Up to 40 mL | ≤ 60 cm H2O | 15 mm OD | Bariatric & High BMI Clinical Scenarios |
The global medical disposables landscape is undergoing a structural paradigm shift driven by stricter regulatory mandates (EU MDR 2017/745, US FDA 510(k) modernization), environmental sustainability demands, and volatile healthcare logistics. Procurement directors, hospital Group Purchasing Organizations (GPOs), and regional distributors must align with manufacturers capable of delivering both regulatory sovereignty and supply chain resilience.
Global Ministries of Health are actively phasing out Phthalate-containing PVC (such as DEHP) due to endocrine-disrupting concerns. The procurement trend heavily favors 100% Liquid Silicone Rubber (LSR) LMAs, which offer zero chemical leaching, superior mucosal biocompatibility, and non-reactive sterilizability.
Future tender compliance requires GS1-compliant UDI barcode labeling down to individual unit pouch packaging. This enables automated hospital inventory management, direct electronic health record (EHR) scanning, and instant batch recall tracking across global medical networks.
Institutional buyers increasingly evaluate scope 1, 2, and 3 carbon emissions. Leading Chinese manufacturers are integrating rooftop photovoltaic solar generation, zero-wastewater recycling, and energy-efficient cleanroom HVAC filtration to lower the embodied carbon per medical device unit.
Combining 36+ years of manufacturing expertise with rigorous cleanroom infrastructure, complete regulatory documentation, and scalable OEM/ODM flexibility.
Our plant operates under certified Quality Management Systems strictly aligned with ISO 13485 and ISO 9001. Product families carry CE marks under EU MDR pathways, backed by full technical dossiers, biocompatibility summaries (ISO 10993), and stability validation data.
Vertically integrated manufacturing spanning raw medical-grade granule compounding, injection molding, tube extrusion, cleanroom assembly, and ultrasonic welding. Eliminates sub-assembly outsourcing defects and ensures consistent batch uniformity.
In-house validated sterilization cycles complying with ISO 11135 and ISO 11137 standards. Every export lot is released against biological indicators, chemical integrators, residual EO limits (<4mg/device), and bioburden testing Certificate of Analysis (CoA).
Full support for private-label brand positioning, including custom artwork proofing, multi-lingual Instructions for Use (IFUs), buyer-specified carton dimensions, customized kit tray configurations, and UDI/GS1 barcoding within 5–7 working days.
Dedicated international export desk supporting FOB, CIF, and CFR shipping modes through major deep-water ports. Proven track record supplying public health tenders, university hospital systems, and commercial distributors across Europe, Middle East, Asia, and Latin America.
Our modern manufacturing campus incorporates heavy rooftop solar energy arrays, reducing fossil fuel grid dependence and ensuring sustainable, eco-friendly production of single-use medical devices for responsible healthcare systems.
Direct technical and commercial answers for hospital procurement officers, tender managers, and global importers.
Our manufacturing facilities operate under a certified ISO 13485 and ISO 9001 Quality Management System. Product ranges hold CE certification under the European Medical Device Regulation (EU MDR 2017/745) pathway. Every export consignment is accompanied by a batch-specific Certificate of Analysis (CoA), Sterilization Release Certificate, Bioburden Release Test Data, and Free Sale Certificate (FSC). Complete Technical Files, including ISO 10993 biocompatibility testing, physical strength, leak resistance, and accelerated stability data, are available for Ministry of Health registrations worldwide.
We supply both 100% Medical Grade Liquid Silicone Rubber (LSR) and DEHP-Free Medical Grade PVC Laryngeal Masks. Silicone LMAs offer superior cuff flexibility, remain inert during prolonged anesthesia, eliminate phthalate leaching risk, and provide higher seal pressures under lower intra-cuff inflation volumes. PVC LMAs provide a cost-effective alternative for short elective surgical procedures and high-volume emergency trauma kits. Both material options are latex-free and feature soft, atraumatic anatomical cuffs.
Standard catalogue items typically start at an MOQ of 1,000 units per SKU or one pallet load. Private-label OEM programs (customized packaging artwork, multi-lingual IFUs, customized kit components) begin at a single mixed 20-foot container load. Standard catalog orders ship within 3 to 4 weeks after order confirmation. OEM orders requiring new packaging setup or registration legalization typically require 4 to 6 weeks from final digital artwork proof approval.
Our single-use devices undergo validated Ethylene Oxide (EO) gas sterilization or Gamma Irradiation in strict accordance with ISO 11135 and ISO 11137 standards. Sterility Assurance Level (SAL) of 10-6 is maintained. Each production batch is monitored using physical parameters, chemical integrators, and biological indicators (Bacillus atrophaeus). EO gas aeration parameters ensure residual levels remain well below ISO 10993-7 thresholds prior to warehouse quarantine release.
Yes. Our in-house Regulatory Affairs team routinely prepares legalised, notarized, and apostilled documentation required by Ministries of Health across the Middle East, Africa, Latin America, CIS, and Southeast Asia. We supply STED (Summary Technical Documentation), CE Declaration of Conformity, FSC, ISO 13485 certificates, clinical evaluation reports (CER), and stability testing dossiers formatted specifically to local authority guidelines.
Our double and triple lumen hemodialysis catheters incorporate staggered arterial and venous tip openings to prevent blood re-uptake and lower recirculation rates to under 2%. The lumen geometry is designed with optimal D-shape or double-O cross-sections to maximize internal cross-sectional area, allowing flow rates above 400 mL/min at arterial pressures under -200 mmHg while reducing shear stress and red blood cell hemolysis.
Connect directly with our senior engineering and regulatory team to request technical specification sheets, factory audit reports, sample kits, and competitive FOB/CIF quotation terms.
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