Respiratory safety masks purchased from China with European money have proved to be of the lowest quality, an investigation by Bivol showed. A US assessment laboratory has tested dozens of models of Chinese masks and has given their manufacturer, Ryzur, the lowest rating for filtration i.e. maximum filter efficiency of 34% instead of the expected maximum of 95%. In short, they need to be discarded. In addition, the Chinese company is not on the “white list” of the US Food and Drug Administration (FDA) but uses its logo on its certificates, which reeks of fraud.
The masks in question are part of a government order, boisterously touted as a personal achievement of Bulgarian Prime Minister Boyko Borisov, who has negotiated with his Chinese counterpart a delivery of 1 176 770 pieces worth EUR 1 412 124. The Ministry of Health has purchased them with funding from the European Union’s (EU) Operational Program “Regions in Growth”. The masks should be distributed to the employees of the regional health inspectorates, the bodies of the Ministry of the Interior and the Ministry of Defense, the Customs Agency, as well as to the employees of other institutions working at border checkpoints.
Ordinary surgical masks filter about 30% of airborne particles and bacteria. Basically, they do not protect the wearer from the virus but protect only those around them. The high-end masks, the so-called facepiece respirators, filter 95%. They are designated FFP2 (EN 149-2001) under the European standard, N95 (NIOSH-42C FR84) under the US standard or KN95 (GB2626-2006) under the Chinese one. In theory, the FFP2 mask stops all particles, bacteria and viruses and is a good enough protection for the wearer if they put it on and use it properly.
So far, two shipments of masks have arrived and the second came on May 2, 2020, on board the national flag career Bulgaria Air. The press office of the Ministry of Foreign Affairs disseminated photos, which showed that these were masks of the KN95 type from the manufacturer Ryzur.
The FFP2 logo is also clearly visible on the boxes with the Chinese masks. The full name of their manufacturer is Anhui RYZUR Medical Equipment Manufacturing Co., Ltd. It makes surgical masks, protective KN95 respiratory masks, according to the GB2626 standard (see here) and medical KN95 respiratory masks, according to the GB19083-2010 standard (see here). The manufacturer’s reference for regular masks is RZ95B and for medical masks, it is RZ95A.
The masks that landed on May 2, 2020, and were described in the government press release as “protective”, are RZ95B masks. This is evident from box labels, which say disposable particulate respirator Face Mask KN95, not medical respirators.
The US National Personal Protective Technology Laboratory (NPPTL), which is part of the Centers for Disease Control and Prevention (CDC) has tested exactly this respirator model of the GB2626 standard. The assessment has been conducted at the end of April 2020 and addresses only filtration efficiency, not whether the mask fits snugly on the face.
Among the 92 models studied (see here), the Ryzur mask has performed the worst. The maximum filter efficiency of this mask is only 33.9%! This is outrageously low compared to the stated 95% for this class of respirators. Actually, this mask does not at all protect from coronavirus. The full assessment report can be viewed here.
Three quality stamps and how many fakes?
The packaging of the masks shows that the manufacturer claims that its product meets the FFP2 standard, that it is approved for use by the strict FDA and has the CE marking of the EU, indicating they are made according to European Economic Area standards.
However, the US lab’s assessment shows that the FFP2 stamp on the packaging is false. A product of this quality must filter 95% of airborne particles, but this one does not.
Bivol searched for copies of the FDA and CE certificates for these masks.
Despite the poor quality of the copies in our possession, one can see that the certificate with the FDA logo is not a certificate of product approval issued by the US agency. The document has been issued by an intermediary in China that has registered this product in the database of the US agency as a candidate for approval.
This is a commonly used trick by Chinese manufacturers, which register their products in the FDA system and proudly tout them as “FDA registered”. However, the difference is like enrolling in driving school and having a driving license.
By the way, the FDA has published an official list of authorized respirators from China, which does not include a manufacturer named Ryzur.
The other certificate for a product authorized in the European Union looks authentic. It is quite new, from March 17, 2020, or before the US laboratory’s assessment of the masks that has found them to be of very poor filtration quality.
Another epic fail with protective gear
The import of masks that do not meet the standards is just one in the series of failures of the government’s despite it boisterously advertised actions to provide personal protective gear and equipment to fight the coronavirus.
As Bivol has already revealed, the UAE sent dates instead of masks and hand sanitizer gel with methyl alcohol.
The ventilators bought at double the price have not arrived yet, but British medics have warned that the products of this company are dangerous because of poor quality.
Fortunately, the masks are not intended for medical use and their low quality would not endanger the health and lives of medical professionals. It remains to be seen whether the government will distribute the masks to police and customs officers, or will return them to the Chinese manufacturer, as did the governments of Spain, the Netherlands, Turkey and Australia, which returned millions of masks?
A tough question given the thriving Bulgarian-Chinese friendship.
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