The EU will implement new regulations (MDR) on medical devices from May 2021. In order to meet the new requirements, ALEEN has made corresponding adjustments and improvements to the technical specifications related to masks and registered them again in the EU.
ALEEN’s KN95 masks are listed by the FDA and can continue to be sold in the US and North American markets in the new year.
The United States issued a new standard ASTM F3502-2021 for ordinary face masks, and ALEEN’s KN95 masks were tested under this standard, and the results were all qualified, providing confidence and assurance for the product to be sold in the United States and North America
According to relevant Chinese regulations, ALEEN’s KN95 masks have updated the implementation standards, and have been tested corresponding to GB2626-2019, and the results are all qualified with high standards
After a series of technical preparations and applications, ALEEN medical masks passed the 510(k) approval of the US FDA and obtained the qualification to be listed in the US medical market.There are two types of medical masks that have passed the application this time: ear-loop type and tie-on type.
In August 2020, ALEEN medical masks are ready to enter the U.S. market. Intertek, a well-known international organization, is responsible for testing. It has passed relevant tests such as biocompatibility and ASTM F2100, and the results have reached the highest level.