What if NIOSH Certification is not Available to N95 Mask Manufacturer?

NIOSH is the top most certifying authority for face masks, particularly for the N95 and the N99 masks. The agency is noted for defining stringent testing and certifying criteria for the face masks which makes it highly reputed worldwide. Face mask manufacturers from around the world would surely like to get NIOSH certifications for their masks as this directly impacts their sale in their own country. This certification also opens the gates for the manufacturers from other countries to export these to USA and Canada. They can expect to get good orders from the large US manufacturers and also from other parts of the world.

Why Certification is Not Easy?

But, getting this certification is not easy. The reasons for the same are not difficult to fathom. At first, the product has to be really top-notch. This means that top grade material has been used to manufacture these using the state-of-the-art equipment for the purpose of meeting quality standards. Further, there is a need to invest in building the in-house testing capacities and have a clearly defined process of manufacturing which ensures that the quality is ensured consistently and without any issue at any time.

Sending for Approval

Further, after the development of initial samples, the N95 mask manufacturer is required to send these to the NIOSH in USA for testing and certification. However, herein lies the biggest challenge. The process of applying for it and the documentation required is such that a vast number of the organizations are not able to meet the criteria. Even those which do meet the criteria might still not get their sample tested due to sheer number of samples coming to NIOSH. Further, NIOSH would like to remain reasonably assured that after the grant of certification, the desired level of quality will continue to be delivered. It would like to maintain some kind of check in the after-approval phase to ensure that the products do not compromise on quality front.

What is the Alternative?

If the samples do not adhere to the quality parameters, these are liable to be rejected. However, what about the samples which are never considered for testing? What options manufacturers have in that scenario?

Well, there are other agencies as well which provide the certifications and these are equally reliable. FDA is one such organization within the USA which does this. Similarly, there could be certifying agencies within manufacturer’s own country which would be able to do the needful. One needs to find these agencies. Manufacturers can go for testing from a number of such agencies, if not NIOSH, just to ensure that quality check is thorough and the mask is able to provide desired level of protection to the wearer.

Do alternative approaches help in business?

With the kind of demand that exists at present for the N95 masks, it is good to assume that all are not going to get the NIOSH certified masks. Therefore, there is a good part of the domestic as well as international market which would be able to absorb excellent quality n95 masks, even if these are not NIOSH certified.