Industry News

FDA mask

2020-04-08
American mask FDA standards and certification requirements
US FDA certification requirements for general protective masks:
According to the US FDA medical category I certification, the process is:
① Fill in the application form and confirm the information;
②Get the PIN code and pay the annual fee;
③ Issue the registration number;
④Product export.
American medical surgical mask certification requirements:
According to the US FDA medical category II certification, the process is:
①Product testing (performance testing, biological testing); e68a84e799bee5baa631333433623735
② Prepare 510K documents and submit to FDA for review;
③ FDA issued a 510K approval letter;
④Complete factory registration and machine listing;
⑤ Product export.
U.S. medical N95 and above 9 mask certification requirements:
According to the NIOSH certification standard, enterprises need to send samples to the NIOSH laboratory for testing, and submit technical information (including quality system part information) to the NIOSH document review. After the document review and test are passed, NIOSH approves and issues approval.

Previous:

Mask CE