Tianfu Roud, Dongcheng District,Shan County, Heze City, Shandong, China 274300
Preface: The medical surgical face mask of Shandong haidike Medical Products Co., Ltd. has been certified by FDA 510 (K) of the United States. Haidike medical surgical masks can be exported to the United States with guaranteed quality.
What is 510K?
Medical devices are divided into I, II and III categories. The classification of all medical devices is published in federal regulations according to their intended use, of which about 46% are class I products, 47% are class II products and 7% are class III products. Medical devices enter the U.S. market through exemption, 510 (k) and PMA. According to FDA statistics, at present, about 7% of class I products, 92% of class II products, 80% of class III products need 510 (K) applications, and 20% of class III products need PMA applications.
510 (K) refers to the application document submitted to FDA for approval of a medical device to enter the U.S. market. Pre market notification, which is named after the document corresponding to chapter 510 of FD&C Act of the United States. For any product, enterprises need to carry out enterprise registration and product listing. For high-risk products, we need to complete 510 (K) test, product comparison, report writing, official review and FDA certification of enterprises and devices.
Surgical face masks exported to the United States, FDA 510 (k) certification is the most reliable
In March and April last year, FDA released several EUA routes for mask products to expand the supply capacity of masks during the epidemic. The products covered by EUA include non-surgical medical masks, kn95 masks and N95 masks. There are corresponding policy statements for surgical masks in the enforcement policy. Under the premise of meeting certain use restrictions and testing standards, no 510 (k) will not be rejected by FDA. However, for a period of time, the qualification of masks applied for export through EUA mode was temporary and unstable. So, if we want to obtain stable export qualification, we should declare 510 (k) for medical surgical masks.
The medical surgical face mask produced by Shandong Haidike Medical Products Co., Ltd. has been certified by FDA 510 (k). If you need to export masks to the United States, you can contact us.