Updated: Feb 27
The National Institution of Occupational Safety and Health (NIOSH) in the United States is and the only agency authorized to issue N95 series (including N99/N100 and other P, R series and other professional respirators) qualifications, which need to undergo manufacturer audits and product testing. On top of that, Surgical N95 respirators also require FDA certification and registration.
All qualified N95 or Surgical N95 will be published on the websites of the US Centers for Disease Control, CDC and NIOSH, and obtain the unique TC-84A series number with manufacturer information. Failure to provide a number or a number inconsistent with the manufacturer is considered counterfeit.
During the outbreak of the pandemic, the US NIOSH agency has stopped providing certification for non-US medical enterprises outside the United States. The US government has repeatedly asked relevant manufacturers to give priority to the supply of products in the United States. Therefore, supply of medical-grade N95 (Surgical N95) almost ceased in the overseas out of US. Not even new manufacturers have been able to apply for manufacturing.
At the end of 2020, the World Health Organization (WHO) issued grade guidelines for global masks & respirators (and other PPEs). Taking the EU standard as an example: if the respirator meets the EN14683 type IIR (medical) & EN149 FFP2 NR (industrial protection) standards simultaneously, its efficacy is equivalent to the US "medical grade" N95 (Surgical N95). It’s collectively referred to as “fluid resistant particulate respirator”, or “Surgical respirator” in short.
Because of the difficulty to achieve this high recognition double certification, some suppliers intend to pass their products off as achieving the standards, by making two different batches of respirators with the same appearance but made of different materials, and send them to different certification bodies to obtain certification separately. For EN14683 Type IIR (medical) certification, they use higher permeability filter layer and liquid proof surface layer cloth. In EN149 FFP2 NR (protection), the filter layer with strong filtering capacity is changed to obtain medical and protection recognition respectively, plus the actual production and sales of the product do not meet the requirements of (medical + protection) at the same time. Users should pay attention to this extremely irresponsible practice that will surely harbor serious consequences.
World Health organization. (2020, November 13). Technical specifications of personal protective equipment for covid-19. World Health Organization. Retrieved February 3, 2022, from https://www.who.int/publications/i/item/WHO-2019-nCoV-PPE_specifications-2020.1
Update : 20220203-Chiupdate 20220203-Eng