On May 7, 2020, the U.S. Food and Drug Administration (FDA) revised and re-issued its Emergency Use Authorization (EUA) on Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China such as KN95s.
FDA Has Strengthened Its Quality Control Of China’s KN95 Respirators
Due to quality concerns and actual test results, the FDA revised its COVID-19 authorization criteria as follows:
- It is manufactured by an entity that holds one or more NIOSH approvals for other
models of FFRs produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA; or
- It has a regulatory authorization under a jurisdiction, including the Chinese National Medical Products Administration (NMPA) registration certification by an appropriate
provincial or municipal regulatory authority, that can be authenticated and verified by FDA; or
- It was previously listed in Appendix A under the April 3, 2020 letter of authorization as
an authorized respirator because it demonstrated acceptable performance to applicable standards as documented by test reports, has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEBAPR-STP-0059 within 45 calendar days of the date of issuance of this EUA, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent.
A Much-Reduced List of FDA Authorized N95-Equivalent Respirators from China
As part of this EUA re-issuance, FDA also removed a fairly large number of China-made respirators that do not meet the revised authorization criteria. As of May 7, 2017, only 14 Chinese manufacturers remain on this FDA authorized list of China-made respirators.
Buyer Be Aware – How to Choose a KN95 Product From China
Here should be a buyer’s workflow when sourcing a KN95 product from China:
- Be aware that FDA only authorizes the use of KN95s during the COVID-19 outbreak
- Only choose a KN95 authorized to use in the US, from the FDA authorization list.
- Ask the supplier and choose a KN95 product meeting your needs. There are two Chinese national standards for KN95s:
- GB 19083-2010 for medical protective use. Filter particulate matter in the air, and block the droplets, blood, body fluids, secretions, etc. in the medical working environment. To qualify to exportation, a medical KN95 product compliant with GB 19083-2010 must be properly registered with China’s NMPA (counterpart of US FDA).
- GB 2626-2006 for industrial protective use. Protect users from various types of particulate matter. As for non-medical use, GB 2626-2006 compliant KN95s do not need to register with NMPA before exporting out of China.
You can count on GreenPPE team to find the best PPE products for your needs at the best price. Let’s team up.