We utilizes a complete quality management system ISO9001, ISO13485, ISO14001. 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, UKCA. 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 our surgical gowns meet ANSI/AAMI PB70:2012 Level-3 and EN 13795-1:2019 requirements.
At the same time, we have 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.
About Cleanroons:
--Cleanroom face mask workshop in class 100000: all kinds of disposable medical facemask, KN95 folded masks, 3D masks, cleanroom masks, KF94 masks. The daily output is around 5 million pieces totally.
--Cleanroom workshop for clothes in class 100000: all kinds of medical and PPE coveralls, isolation gowns, surgical gowns, lab coats, patient gowns, medical sheets, PE aprons, CPE gowns, raincoats etc. The daily output is around 50 thousands pieces totally. From the material selecting, cutting, sewing, process the accessory, checking, packing to storing, we are serious for every details.
--Cleanroom workshop for headwear and footwear in class 100000:all kinds of headwear and footwear such as nonwoven shoecovers and bootcovers,pe shoecovers and bootcovers, nonwoven bouffant caps, mob cap,hoods etc. The daily output is around 100 thousands pieces totally.
We'll be glad if you'd like to know more details about us. We welcome your visiting to our factory anytime!
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