News Item: Safety Regulator Warns Against KN95 Facemask

HSE experts identified the PPE as suspect and locally arranged testing confirmed they would not meet requirements, including to protect against the ongoing coronavirus pandemic. About 90% of the PPE concerns and queries currently being received by the HSE involve KN95 masks which are often accompanied by fake or fraudulent paperwork.

KN95 is a performance rating under the Chinese standard GB2626:2006, which is broadly equivalent to the EU standard for FFP2 facemasks. But there is no independent certification or assurance of their quality and products manufactured to KN95 rating are declared as compliant by the manufacturer. There is no independent certification or assurance of their quality.


The safety body has quarantined around 1.5 million KN95 masks, prevented 25 million items claiming to be FFP3 respirators entering the supply chain and stopped a further four lines consisting of many millions of items entering the supply chain.

"The KN95 facemask should not be purchased or used," said Rick Brunt, the HSE's director of operational strategy. "KN95 has not been a principal source of PPE for the NHS, who has already made the decision not to supply this respirator to frontline clinicians fighting the coronavirus pandemic.

"We have found that the lack of independent testing has contributed to there being a substantial quantity of inadequate and poor-quality masks on the market, claiming to comply with the KN95 standard.

"We understand a lot of people, mainly in sectors outside of healthcare, have bought these facemasks without realising they are non-compliant. We are concerned that people wearing them are not being protected from breathing in harmful substances in the way they expect. Protective equipment must protect."