About a week ago we wrote an article about sourcing N95 and KN95 respirator masks from China. In the article we discussed testing standards and tips for buying medical PPE overseas.
In a short time things have changed and there are new laws for masks and other PPE from China.
Recently, due to many fraudulently labeled and low quality masks being sent from China to countries all over the world, the Chinese Government imposed some new laws for masks and other PPE exports from China.
And, unlike in the past, when the China Government imposed new laws or standards and turned the other cheek, the Government is checking each and every shipment going out.
For one, masks must be individually packaged and shipped in their case packs, no exceptions.
In the past, in order to maximize space and save on shipping costs, manufacturers and distributors would place the individually packaged masks in a box and ship the case packs separately. Upon arrival, the end user or distributor would then count them out and put them in the corresponding case packs.
Another change is that packaging must identify the correct classification use of medical or non-medical (proof of testing results must be included), as well as the lab-testing standard included on the case packs that hold the individually wrapped masks.
While these standards are a blessing, it can be a bit confusing to understand because some of their lab standards are different from the U.S. required lab standards for medical PPE coming in from China.
Following is an overview of the ‘new’ standards that will be shown on packaging.
For example, when it comes to respirator masks under the FDA emergency use authorization, they require a lab standard of NIOSH-42C, EN 149-2001, or GB 2626-2006 for respirator masks being imported. There are other standards for masks imported from Australia, Korea, and Japan, but since we focus on China imports, we’re going to just focus on the three mentioned.
As discussed in our previous blog post titled: Souring N95 and KN95 respirator masks from China | What to Know, we detail the three standards. In a nutshell, the NIOSH-42C (U.S), EN149-2001 (EU), and the GB2626-2006 (China) are the respective countries standards guidelines for mask protection.
However, in China, they are now introducing a bevy of lab standards to classify masks being produced for export. Also, its’ not known how the U.S. market will manage these different classifications.
EN-149: Respiratory protective devices- filtering half masks to protect against particles – requirements, testing, marking
EN-143: Respiratory protective devices – particle filters – requirements, testing, marking
EN-14683: Surgical masks – Consists of three tests: bacterial filtration efficiency, breathing resistance, and splash resistance.
YY/T 0969-2013: Chinese standard for single use medical facemasks; very similar to the EN-14683. These are not rated for particle filtration efficiency or synthetic blood penetration.
YY 0469-2011: Chinese standard for surgical masks with ≥30% non-oily particles and protection against 2ml of blood.
GB 19083-2010: Chinese standard for sterile respiratory masks for medical use.
GB2626-2006: Chinese standard for industrial respirator face masks. These do not protect against liquid droplets or secretions. Not recommended for medical use.
GB/T32610: Used for protection against air pollutants and in everyday life.
National Medical Products Administration (NMAP)
While these lab standards are not new, we’re not sure how they will be distributed to consumers and healthcare facilities because, in addition to the above standards, all PPE must be certified by China’s National Medical Products Administration (NMAP) if it is to be classified as ‘medical grade’.
Any mask without this registration will be listed only for civilian/consumer use regardless of the testing they underwent. For example, when it comes to respirator masks, even if they are National Institute for Occupational Safety and Health (NIOSH) and FDA approved, if the masks are not certified by NMAP, they will be packaged and sold as non-medical use.
So, obviously getting NMAP certified medical grade masks for the healthcare and public sector is ideal. However, these masks are more costly, and not necessarily any better than respirator masks not certified by NMAP, if sourced through a reputable supplier.
As always, we hope this update provides valuable information for those in need of medical PPE. The new laws for masks and PPE from China looks to be here to stay. So, it’s important to take these laws seriously and follow them. Otherwise, you stand the real chance of not getting your shipment to those who need this critical equipment.
Lastly, ASTM International, a voluntary standards organization is offering a “no cost public access to important ASTM Standards used in the production and testing of personal protective equipment.
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