The following qualifications are required for the production of surgical gowns:
1. production sites, environmental conditions, production equipment and professional and technical personnel adapted to the emergency filed products produced;
2. inspection personnel and inspection equipment for quality inspection of the emergency filed products produced;
3. clean production environment, controlled cleaning environment, meet the testing capacity of product factory inspection, including physical and chemical indicators, microbiological indicators, ethylene oxide residual amount, etc.;
4. quality management personnel and regulatory system personnel appropriate to the quality management system of medical device production;
5. the need for Class II medical device registration certificate and production licence.
In short, the production of surgical gowns need to have certain equipment and personnel qualifications, and at the same time need to strictly comply with relevant laws, regulations and standards.