Recently, the USA and some other nations found faults with the PPEs and testing kits sent by China. This resulted in some states like Georgia canceling their contracts with Chinese manufacturers, offering test kits with low accuracy rates. The constant demand for PPEs and test kits has led to the registration of 38,000 new companies, leading to quality concerns. This Dragon Sourcing newsletter shows the FDA compliance and approval procedure of masks, respirators, gloves and gowns. It tells the reader that, while N95 masks fall under PPE and have to undergo NIOSH certification, surgical masks that are medical devices, come under the FDA purview. To confirm FDA compliance, Dragon Sourcing has identified the suppliers, who can supply to the US, as per the RFI process and request suppliers to send product standards and certified FDA letters. Then, they verify them on fda.gov website where all the approved and registered manufacturers are listed.
