BSIF have provided the answers to the questions asked in good faith and to the best of our ability. BSIF cannot be held legally liable for the answers provided. Some questions have been grouped together where the answer is the same.
Question: We have been advised that KN95 is the Chinese equivalent to FFP2, and that we can purchase if certifications are provided. Is this not correct?
Question: Will companies selling KN95 masks be prosecuted due to the product being non compliant?
Question: There has been much activity concerning KN95 masks. What are the facts? Can a KN95 mask be used in the UK?
Question: We have so many “Importers” offering us FFP2, N95, KN95 masks, and all are saying they are CE marked, so how is that possible on the N95 & KN95 masks ?
Question: Single use/disposable face masks/coverings – for example N95 or NK95 or similar, that millions of us maybe required to wear – are these PPE, Medical devices, or neither? What is the required minimum standard for these, will there be enough available?!! Many thanks.
Question: Can N95 and KN95 masks be imported and used in the UK? What should be provided with these masks?
Question: If a mask is approved by the FDA and is comparable to the EU standard am I correct to assume it cannot be sold in the UK unless meeting the EU standard.
KN95 cannot be assumed to be equivalent to FFP2.Information on RPE varies as to it’s suitability. At this moment in time, it needs to meet the requirements of the PPE Regulation (EU) 2016/425 and EN 149:2001+A1:2009 or in the case of RPE for use against Covid19, to have been subject to the requirements of the (EU) 2020/403 ‘Fast-Track’ assessment processes
Question: What legislation is required for the sale of “Civillian” masks? And what is the difference between a medical mask and a civillian mask in terms of protection?
Civilian Use is not a reference detailed in the PPE Regulation. For RPE in the EU/UK it must comply with either EN 149:2001+A1:2009 or the requirements set out through (EU) 2020/403 for PPE providing protection against Covid19 exposure
Question: The single disposable masks that I have purchased at chemists do not have any manufacturer’s details on them, sources of supply etc. So are they necessary on these?
Difficult to answer without knowing more about the mask – it may be that they are not classed as PPE. If you wish to send details to email@example.com we may be able to help further
Question: with the situation that most FFP3/P2 dust masks are being given to the NHS then how do we overcome this? We are being given (potentially) genuine masks from china or America so how would this work? What supporting docs should we be looking from if from China/USA and what do these look like.
Any RPE should be approved to meet the requirements of the PPE Regulation (EU) 2016/425 and EN 149:2001+A1:2009 or in the case of RPE for use against Covid19, to have been subject to the requirements of the (EU) 2020/403 ‘Fast-Track’ assessment processes. Documents from China or USA are not relevant – only the Declaration Of Conformity and Certification from the Notified body are acceptable
Question: Masks have been purchased from china, voluntary certificate has been issued, where do you stand if issuing to employees?
Currently voluntary certificates have no meaning in relation to PPE legislation. It needs to meet the requirements of the PPE Regulation (EU) 2016/425 and EN 149:2001+A1:2009 or in the case of RPE for use against Covid19, to have been subject to the requirements of the (EU) 2020/403 ‘Fast-Track’ assessment processes – issuing non-compliant product is not permitted
Question: Hello, This is a question around KN95 Masks (FFP2) and in relation to COVID-19. We have seen a number of these masks arrive after placing orders through a number of suppliers. Due to being unsatisfied with certification we have not used the masks. 3M produced a technical bulletin detailing the performance of these masks and the HSE produced a rapid response document detailing that KN95 Masks could be used for healthcare settings. Has the checking of certification been relaxed for healthcare settings? Also, why has it been agreed that KN95 masks can be used for healthcare?
The process via (EU) 2020/403 allows for assessment by a cross government committee to determine the suitability of any PPE. Also Manufacturers can have products assessed by Notified Bodies against 2020/403. PPE that is approved in this manner is ONLY for use against Covid19 exposure and is only approved for a limited timescale
Question: Is anything going to be done about the misinformation with regards selling of PPE? i.e advertising a N95 mask as a FFP3 complying with allegedly EN 149:2001 which are 2 different masks and differing standards.
As mentioned before – it is possible to have N95 product assessed and approved. BSIF are working with the market policing authorities and the Office of Product Safety & Standards to identify any non-compliant product we are made aware of