The Gold Standard in Protection: Our Commitment to Quality & Certifications

2025-09-29 14:17 Rachel from ZHIBO

At Zhibo, quality isn't just a department; it's the bedrock of our identity. We believe that true protection stems from an uncompromising commitment to excellence, validated by the world's most stringent certifications. Our integrated production process is governed by robust quality management systems, including ISO 13485 and ISO 9001, ensuring consistency from raw material to finished product.

We hold both ISO 9001 and the medical-device specific ISO 13485 certifications, underscoring our systematic approach to quality. Our product-specific accreditations provide tangible proof of performance: our medical masks comply with ASTM F2100 (Levels 1-3) and EN 14683 (Type I/II/IIR); our surgical gowns and protective apparel are certified to AAMI PB70 (Levels 1-3) and Type 5/6 standards. Furthermore, our comprehensive portfolio carries CE marking and FDA 510(k) clearances, supported by Chinese Medical Device Production and Registration Licenses. 未标题-4.jpg Our dedication is further proven by our comprehensive portfolio of international certifications. Our medical masks meet the rigorous standards of ASTM F2100 Level 1/2/3 and EN 14683 Type I/II/IIR. Our surgical gowns and protective apparel comply with AAMI PB70 Level 1/2/3 and EN 13795, while our coveralls are certified to Type 5/6 standards. With CE, FDA 510(k), and various medical device production licenses, we don't just meet the bar—we set it.