In the last two articles, we talked about what tricks bad vendors would do to make 0.007USD/pc possible. Today, let’s discuss those stocked masks. Many stocked masks can be sold at an extremely low price, but if we dig deeper there are many things we need to concern about. What are the causes of th
In order to help mask users cope with different risky operation scenarios, countries have strict regulations on the production standards of masks.
In the EU, masks are divided into medical masks and respirators (non-medical) according to their intended use.【Medical masks】need to comply with the medical device regulations EU2017/745 (MDR) or the medical device directive 93/42/EEC (MDD). Medical non-sterile masks can be sold by the manufacturer
【Medical Mask】The US regulatory agency for medical masks is the FDA. There are three classification codes for masks in the FDA system: FXX, OUK & ORW. They all belong to rule 878.4040, and they all need to apply for FDA 510K approval. Since the product code ORW is used for N95 respirators, the produ
In the last article, we talked about what tricks bad vendors would do on face mask materials to cut corners. Today, it is about production and packing. Production MachineAdd alt textWith technology iterating, most of the large-scale face mask manufacturers like us have adopted automatic face mask pr