Level 4 Surgical Gowns
SKU: Surgical-Gowns-1
Surgical Gown Series
High-Performance Viral Barrier Surgical Gown (AAMI Level 4)
• Materials:
Various SMS / Spunlace materials for option
• Types:
Standard / Reinforced / Extra Reinforced / Urology
• Breathable Comfort:
Designed for whole-day wear without compromising protection
• Virus Resistance:
Advanced barrier to prevent virus penetration
• Manufacturing Techniques:
Ultrasonic Sealing / Stitching / Glue welded / Hot Sealing
Product Details
• Performance Standard:
EN 13795 – Standard & High Performance
AAMI PB70 – Level 3 & Level 4 Barrier Protection
More Information
• Standards meet
USA – ASTM F2407-2020, (ANSI/AAMI PB70:2012 Level 3 & 4)（sterile)
EU – ISO 13485:2016, MDR (2017/745), EN 13795-1
China – YY/T 0506 (sterile)
When compromises are not an option. Designed for extreme fluid-intensive procedures and high infection risk environments, this AAMI Level 4 Surgical Gown provides the ultimate biological defense. Constructed with state-of-the-art Breathable Viral Barrier (BVB) laminates or microporous films, it delivers a 100% impervious shield against blood, pathogens, and viruses. Rigorously tested to pass ASTM F1671 and EN 13795 (High Performance) standards, it ensures maximum safety for frontline healthcare professionals without sacrificing mobility.
"Supported by our global manufacturing facilities in Taiwan, China, and Cambodia, we offer scalable production capacity for high-volume bulk orders."
•Technical Specifications
| Category | Optimized Specification |
| Protection Standard | AAMI PB70 Level 4 / EN 13795 High Performance AAMI PB70 Level 4 / EN 13795 Standard Performance |
| Material Safety & Barrier | Compliant with ISO 10993 (Biological Evaluation) |
| Design & Construction | Ultrasonic Welded Seams (Eliminates needle holes), Raglan Sleeves, Low-linting fabric. Diverse Cutting Design, Production Process and Raw Material Selections. |
| Manufacturing Environment | Clean Room - ISO Class 8 |
| Quality Management System | ISO 13485 / MDR Regulation (EU) 2017/745 |
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