FDA 510K Level-3 Steriled Package Disposable Medical Surgical Gown With Knitted Cuffs
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PB70:2012 Level-3 Surgical Gown
Product Information
Features & Pictures
About Us
Hubei TDL Group is made of Hubei Orient International Trading Corporation and Ammex-weida(Hubei) Health and Safety products Co.,Ltd. We specilize in the design,manufacturing and sales of disposable medical products and PPE products for more than 20 years.
Ammex-weida established in 2003,covering 65,000 square meters. We are a group of more than 500 individuals. Ammex-weida is equipped with a medical and industrial laboratory in class 10000, clean room workshops in class 100000 for sterile medical devices and all kinds of disposable products. Our disposable products are exported to more than 60 countries and regions in Europe, America, Asia, Middle East etc.
Ammex-weida utilizes a complete quality management system ISO9001, ISO13485. We care about human rights and we are certified by human right agency of SEDEX. Ammex-weida has medical device license for class I and II. Our products are certified with CE,FDA. Our medical face masks passed through Nelson's test. Our medical face masks are conform to EN14683 type II and type IIR for Europe market, ASTM level 3 510K for North America and the national standard YY0469 and YY0969 for China market. Our category III protective coveralls are complied with new European PPE Regulations (EU)2016/425. They are classified to type 3/4/5/6 and 3B/4B/5B/6B. And we' ve passed AAMI PB70:2012 Level-3 test for disposable surgical gown.
Our group has more than 20 individuals for QC quality control, laboratory and inspection.Our laboratory could do tests for face masks such as particulate filtration efficiency, differential pressure, Synthetic blood penetration,Tensile test for earloop,flammability test,microbial cleanliness,splash resistance,sterile test, ethylene oxide residue etc.And also we could do tests for coveralls such as hydro-static pressure, Repellency by liquids, Resistance to Penetration by liquids,Surface Resistance, Resistance to Ignition,filtering efficiency,Puncture Resistance,Tensile strength,static decay period,sterile test, ethylene oxide residue etc.
Ammex-weida is situated in Xiantao,Hubei province,the famous nonwoven products base in China.Almost 50% disposable nonwoven medical products and nonwoven healthcare products are produced in Xiantao.The traffic is very convenient. Xiantao is 100km from Wuhan Yangluo port,100km from Wuhan Tianhe airport, 10km from Xiantao railway station.
Ammex-weida welcomes you!
FAQ
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