The FDA has removed respirators made by 60 companies in China from its emergency use authorization list for COVID-19 over concerns that they may be “sub-standard.”
The list, which had totaled 74 manufacturers when issued April 24, still includes 15 models of N95 respirators made in China by 3M (NYSE:MMM), plus a number of models made by 13 Chinese companies. The FDA issued its first respirator EUA list March 24, including masks made by companies in Europe, Australia, Brazil, Japan, Korea and Mexico. At the time, the agency declined to authorize respirators made in China for use by U.S. healthcare workers over concerns about fraudulent masks.