Due to the national standards of the United States, non-woven isolation garments are divided into different grades.
The AAMI standard specifications promulgated by the American Association for the Advancement of Medical Devices classify the protective performance of isolation gowns:
Protection level AAMI Level 1-4
Level 1 (Level 1) isolation clothing must undergo an impact penetration (Impact Penetration) waterproof test. The water penetration must be less than 4.5 g;
Level 2 (Level 2) must undergo two tests, impact penetration waterproofing and hydrostatic pressure. The water seepage volume of the former must be less than 1.0 g, and the hydrostatic pressure of the latter must be greater than 20 cm H2O;
For Level 3 (Level 3), the water seepage must be less than 1.0 g, and the hydrostatic pressure test must be greater than 50 cm H2O;
Level 4 (Level 4) For surgical gowns or other protective clothing, both blood and virus leakage tests must be passed. The water repellency of surgical gowns and bedding must be kept at 13.8kPa (equivalent to 140 cm H2O) for 1 minute. The blood must not penetrate, and the microbial penetration test must be carried out. Phi-X174 phage must not penetrate. Due to the high requirements of this standard, 510K will be required to go to the United States.
About Wellmien
Founded in 2006, Wellmien has grown to a company specializing in disposable medical supplies and Personal Protection Equipment (PPE), integrating with design, manufacture and sales capacity. Our sales headquarter is in Suzhou, Jiangsu and manufacturing plants cover a total area of 8,000m2 including 1,500m2 of clean room.
Wellmien provides globally medical care and food processing facilities with products including face masks, gowns, coveralls, aprons, bouffant caps, shoe covers, sleeve covers, under pads, disposable gloves, wound-care products, surgical gowns, first-aid products and surgical packs etc. Our products are best sold to worldwide markets and widely applied to different settings such as hospitals, care centers, wholesalers, government agencies or institutes, food industries and households, etc. With excellent OEM services, our annual sales exceed 20 million USD.
Wellmien is ISO13485 certified and implements a strict Quality Management System (QMS). Our main products are approved by US FDA and EU CE certified. With superior products and services, our company has won the trust and support from new and old customers all over the world. If you have any inquiry, please do not hesitate to contact us!