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Safety Alert - Use of KN95 face mask as PPE
17 June 2020
KN95 face masks lack compliance with European standards and provide an inadequate level of protection and are likely to be accompanied by fake paperwork.
Face masks claiming to be of KN95 standard provide an inadequate level of protection and are likely to be poor quality products accompanied by fake or fraudulent paperwork. These face masks may also be known as filtering facepiece respirators.
KN95 is a performance rating under the Chinese standard GB2626:2006, the requirements of which are broadly the same as the European standard BSEN149:2001+A1:2009 for FFP2 face masks. However, there is no independent certification or assurance of their quality and products manufactured to KN95 rating are declared as compliant by the manufacturer.
Personal Protective Equipment (PPE) cannot be sold or supplied as PPE unless it is CE marked. The only exception is for PPE that is organised by the UK Government for use by NHS or other healthcare workers where assessments have been undertaken by HSE as the Market Surveillance Authority.
What you need to know
There is a clear difference between a surgical mask, a face covering and a face mask such as an FFP3 or FFP2. The surgical mask may offer protection from the wearers’ breath being expelled and thus offering some protection to those around. A face covering is a homemade variation of the same.
When people say face mask they are probably referring to a dust mask style face mask and recently the filter level has been used a lot in describing these in the media – often N95 (an American standard) or FFP3 and FFP2. This stands for Filtering Face Piece Particulate Filter ‘3’ and ‘2’. The technical term for these types of masks is RPE – Respiratory Protective Equipment. FFP3 is the higher level of filtration and is recommended, in relation to COVID-19, for health care professions partaking in aerosol generating procedures – those with the highest likelihood of airborne release of virus from an infected person.
Additionally, it may be appropriate to try either the 3M 9332, 3M 8835 or Alpha Solway Alpha-S immediately as alternatives. Specifically, the Alpha Solway Alpha-S is designed for those with smaller faces who may fail fit testing on other models.
Action to be taken
KN95 must not be used as PPE at work as their effectiveness cannot be assured.
Masks that are not CE marked and cannot be shown to be compliant must be removed from supply immediately. If these masks have not been through the necessary safety assessments, their effectiveness in controlling risks to health cannot be assured for anyone buying or using them. They are unlikely to provide the protection expected or required.
If masks are CE marked, suppliers must be able to demonstrate how they know the documentation and CE marking is genuine, supported by Notified Body documentation showing compliance with the essential health and safety requirements as required by the Personal Protective Equipment Regulations (EU) 2016/425.