- N95 masks are the gold standard for preventing the transmission of Covid-19 in a heath care environment.
- But global markets have been flooded with fake equivalents and a range of Chinese-made KN95 mask.
- A recent study by UCT found that 12 manufacturers were selling ineffective KN95 masks onto SA's frontlines.
- And some South Africa stores are also carrying dodgy-looking masks with claims that they are N95 and KN95 certified.
- Here's how to tell if yours is one of them.
- For more stories go to www.BusinessInsider.co.za.
Since the start of the Covid-19 pandemic, N95 respirator masks have been widely accepted as the gold standard. If worn correctly, these masks provide better protection against the coronavirus than lesser face masks.
When manufactured to the correct specifications, their Chinese equivalent, the KN95 mask, is considered to be an alternative line of defence that healthcare workers can use to reduce the risk of infection.
At the start of the pandemic, legitimate masks of this standard were in short supply – even for frontline healthcare workers in leading hospitals around the world. And until recently, getting your face into one as a concerned member of the public was nearly impossible and, in most cases, is still not necessarily recommended.
As the pandemic has worn on, though, the availability of personal protective equipment like certified masks has improved, and masks purporting to meet N95 or KN95 standards – essentially capable of filtering out 95% of harmful airborne particles – have started appearing online and in stores for the general public.
Masks fitting the description and appearance of N95, or KN95, are now selling for as little as R10 a unit. But proving whether they are as effective as their titles suggest is complex, even for healthcare officials.
Fake KN95 masks are reaching frontline workers in South Africa
A veritable flood of personal protective equipment entered South Africa during the early days of the Covid-19 pandemic, much of it imported from China.
A recent study into 12 brands of KN95 masks marketed for use in healthcare facilities in South Africa found that not one met the requirements to adequately protect healthcare workers. In most cases, they failed to meet the regulatory requirements set by American and European regulators.
The study, published in the South African Medical Journal, aimed to evaluate the “seal, fit and filtration efficiency” of several brands of KN95 respirators.
Professor Keertan Dheda, who contributed to the study, told Business Insider South Africa that most did not even meet the minimum requirements in terms of labelling, which is an immediate warning sign for any mask or respirator.
“According to the regulations you’re supposed to have annotated on the mask the details and specifications - that was only present in 16% of those masks. So immediately they don’t pass the standard,” Dheda says. “Then, when we cut the masks open, the numbers of layers within the masks varied from three to six.”
Equally poor was the fit of the masks in question, a crucial factor for frontline workers.
“These masks are supposed to provide a tight seal around the top and sides of the nose, and around the mouth and the chin area - to protect against dangerous pathogens, like TB, influenza and Covid-19,” says Dheda.
The team of doctors tested three masks from the 12 brands, and all failed either the filtration test (not filtering enough particles) or the inward mask leakage test (not forming a tight enough seal), rendering them ineffective in a healthcare environment.
Only 50% of the masks achieved minimum filtration requirements, and the study concluded that the “KN95 masks tested failed the stipulated safety thresholds associated with protection of healthcare workers against airborne pathogens such as SARS-CoV-2”.
South Africa is not alone in this - fake masks have leaked into supply chains around the world, including the United States. And in late October, customs officials in Hong Kong seized a haul of fake N95 masks worth nearly R6 million, which were destined for overseas markets.
Consumers are also being duped
Although healthcare workers risk the most from fake masks, consumers may also be duped into buying masks with N95 or KN95 branding, thinking they’re getting a superior product over other masks on the market.
In June this year, online retailer Takealot removed some N95 masks from its store, pending an investigation into their authenticity. A user had contacted Business Insider South Africa to complain that a pack of ten supposedly N95-rated face masks, which sold for R450, were of poor quality.
“On opening the package and trying one on, I realised that something is wrong as I could breathe easier through this mask than through the homemade sewn mask I had purchased from a local seamstress,” said the reader.
Following the report, Takealot removed the mask from its store, but a search by Business Insider South Africa in December shows that there are now more than a dozen masks on the store still referencing, or directly claiming, N95 or KN95 status.
Prices for these masks have dropped significantly. Many are listed at less than R10 a mask when bought in packs of 10 or 20.
One of the cheapest masks currently available on Takealot is sold by Nexco through Takealot's Marketplace - a third-party marketplace facilitated by Takealot on behalf of “trusted” sellers.
Along with luggage and shoes, Nexco also sells a pack of 10 “KN95 masks”. They cost just R110, or R11 each, and purport to “effectively filter particles in the air”. However, some users describe nose clips falling off, being sent children’s sizes, and masks being generally poor quality.
Business Insider South Africa tried to reach Nexco on its listed number and via email to enquire about the certification of these masks, but was unsuccessful.
Another company using Takealot’s Marketplace to sell “N95” masks is Edgy Sales.
The company is selling what it claims are “N95 Medical Grade” masks in a pack of 10, that costs R520. The masks, made by Chinese company God Bless Well, are labelled N95, and one of its local distributors claims to have an N95 test report - but God Bless Well is not listed as an approved manufacturer of N95 masks in the United States.
Aside from a small selection of “N95 masks”, Edgy Sales sells video games and computer equipment.
Medical supplies company Lomaen Medical is also selling what claim to be both N95 and KN95 masks on the Takealot Marketplace. Their cheapest option, a two pack of KN95 masks, costs just R14, or R7 each.
The company is also selling a mask described as “N95 FFP2”. N95 and FFP2 are the United States and European standards respectively; the image that accompanies the mask carries a GB approval number, which is used for China national standards. Using the United States’s Centers for Disease Control and Prevention guidelines about whether a mask can be called N95 or not, with no NIOSH markings, and ear loops instead of head straps, it immediately can be ruled out as an official N95 mask as labelled.
Wayne Elliott, Managing Director of Lomaen Medical, told Business Insider SA that the company is mainly focused on selling their medical masks to hospitals - and that they “meet European CE standards”.
Elliot says he has “no idea” whether the masks the company is importing and targeting at hospitals meet the requirements of US or Chinese regulators in order to be officially classified as N95 or KN95, which would ensure healthcare worker safety, but instead he is satisfied by CE certifications.
“CE is the European standard for qualification, and FDA is the American standard certification. The masks that we import are CE certified by a European body, and we have a 20 page lab testing document,” Elliot says.
The Lomaen Medical website links to a “CE Certificate” beneath a listing of what the company calls an N95 mask - but this certificate, issued by Italian company Ente Certificazione Macchine, does not appear to be an official CE certificate, and instead a private document that states:
“It is our opinion that the Technical Documentation shared with us by the manufacturer is compatible with the European Standard for Medical Devices. The manufacturer is responsible for the CE Marking and process, and not exempted to carry out necessary compliance activities.”
The Chinese-based company that manufactures some of the masks sold by Lomaen Medical, Hunan Yunbang Bio-pharmaceutical, submitted its mask to the CDC for approval in September. Although the CDC found the mask to have similar filtration properties as N95 masks, they did not award the product with the status owing to some limitations - primarily around fitment, a crucial factor in keeping healthcare workers safe.
Mainstream retailers like Makro and Dis-Chem are also selling similar masks, but none purport to meet N95 standards, and instead fall into the KN95 category.
Makro is selling a 10 pack of KN95 masks for R300, while Dis-Chem is selling a 10 pack made by Rich Resource in China for R169.
These same line of masks sold by Dis-Chem made US headlines in May, when it was revealed that a former White House official won a R45 million contract to supply the masks to hospital, despite them not having the requisite Food and Drug Administration approval “for use in healthcare settings by health care providers.”
Even so, masks sold to the general public at stores and online do not need to meet the more stringent requirements of hospitals and healthcare facilities, and they are not necessarily ineffective when it comes to filtration. But their clinical styling and inclusion of labels like N95 and KN95 are misleading, and may offer a false sense of security.
Identifying legitimate masks is possible, if tricky
“The acronyms can become confusing. Broadly speaking, you have what we call the cloth masks, which are the do-it-yourself masks that people wear and that you can buy. Then you get various types of masks that healthcare workers wear, which can be divided into surgical masks and face-piece respirators,” says Dheda.
These “facepiece respirators” must meet certain fit and filtration requirements, which depending on where they’re approved will be called different things.
“In the USA, the regulatory standard is called N95, in Europe it’s called FFP2, and the Chinese standard is called KN95,” says Dheda.
Although these masks are making their way into stores, Dheda points out that masks for healthcare workers and the general public are not the same.
“Masks for the community are different, because the aims are different. With the community-based masks the main objective is to stop droplets spreading, so others don’t get sick. They would still have some efficiency even if the fit isn’t perfect. So the stakes are different, and the requirements are different,” says Dheda.
As masks with misleading labels and claims continue to spread, the US’s Centers for Disease Control and Prevention has released a list of red flags to look out for when trying to ascertain an official N95 mask’s authenticity - and misstating or appropriating accreditation is one of them.
- Third-party marketplace listings that assure buyers masks are “legitimate” and “genuine”
- Reviews from users claiming poor or cheap construction
- Price deviations and fluctuations, particularly if prices are too good to be true
- No official markings or text on the mask at all
- No approval number on the face piece or headband
- Spelling mistakes and typos on masks and packaging
- NIOSH (the US’s National Institute for Occupational Safety and Health) spelled incorrectly, or not included at all
- Stylish additions, like sequins or decorative fabric
- N95 masks for children; NIOSH has not approved any N95 masks for children
- Ear loops instead of headbands; N95 masks only have headbands
Fake Chinese-made KN95 masks are more difficult to identify, given that, according to the UK’s Health and Safety department, KN95 mask manufacturers can make the claims without independent certification.
There are, however, some basic tests you can conduct on a sacrificial mask, that some say will offer insights into its efficacy. KN95 masks won’t flare up when burned, but rather will melt; they should be water tight when filled from the inside; and the fabric on legitimate masks makes it difficult to blow out a flame ignited in front of your face.
Ultimately, though, Dheda says at a community level, purchasing a mask claiming to be of this standard may not be necessary, and the difference between a cloth mask and a so-called N95 or KN95 mask may be somewhat negligible.
“Once you use that KN95 logo you are implying a certain standard - but if they don’t meet the standard, they shouldn’t be calling them KN95, they should be calling them masks,” he says. “And the KN95s available to the general public would probably be as effective as any cloth masks."