In early March, the WHO called on industry to increase manufacturing of PPE by 40% because of the huge demand the market was facing. Indeed, due to the outbreak of covid-19, masks started becoming a necessity, and later mandatory. However, there are major differences between the types of masks that are manufactured and then traded between countries, so don’t let yourselves get confused!
We often think “well, as long as we have a mask that covers my face, we are safe and sound”, but unfortunately, it does not really work like that. We mean, don’t get us wrong, your logic makes a lot of sense, it is just that the matter goes far beyond this point. There is much more regulation and legislation behind before a single mask is sold and recognized as “certified”, therefore be careful with what you buy. Again, because we inhabit a fairly democratic society, you are more or less free to buy whatever suits your needs best, no doubt about it. But the thing is: why spend money on a mask that guarantees you a low efficiency or in some cases no efficiency at all, when you could spend slightly more for a product that is approved and certified, and gives you the maximum protection? In this article, we will not attempt to change your mind about what you believe or don’t believe masks are - everybody has their own judgements, and we are okay with it. We will try, however, to open your eyes a bit more on what it means to produce and purchase masks that are certified and follow the European or international standards (depending on the market you are buying from). Moreover, we will guide you through the process of obtaining a face masks certification, which is definitely no easy matter! That is why we strongly advise you to be cautious with what you buy, since all that glitters ain’t gold.
We will start off by saying that 89 million of medical face masks are required each month, which is indeed a staggering number. Because masks are being produced in large amounts and their importance is now recognized on a global level, Menut believes it is about finding the right balance between the highest filtration for the bacteria, and in the meantime, the comfort of breathing through it all day long. The point is exactly this, however this is oftentimes mistaken; it is not only about aesthetics (although that is, of course, a relevant variable) and comfort, but is first and foremost about certification, functionality and efficiency. We are sure you all want to feel safe when wearing a mask, right? So do we!
All design, manufacture and marketing of personal protective equipment follow the Regulation (EU) 2016/425 of 9 March 2016 (PPE regulation). This defines legal obligations to ensure that PPE on the EU internal market provides the highest level of protection against risks. After having pointed this out, let’s get started with the real deal! A first difference that is worth pointing out is that between surgical face masks and respirators (those with valves). Surgical face masks, despite being comfortable and overall good, are not recognized as PPE, but only as a general medical device. Nevertheless, they also need to undergo standard practices in order to be certified, and must follow the Directive 93/42 - to be replace by Regulation 2017/745. In the EU, medical devices are split into four classes — I, IIa, IIb and III — with Class III devices being the most stringently assessed. Surgical face masks are identified as Class I medical devices and must meet the design and safety requirements of the Medical Device Regulations (MDD/MDR) as well as being CE (European Conformity Marking) marked before you can sell them in Europe. The CE marking affixed to PPE provides evidence of compliance of the product with the applicable EU legislation, therefore be mindful of this! A completely different story concerns respirators masks (for example FFP3 or N95); indeed, they are considered as PPE equipment by both the European Union and the Food and Drug Administration (FDA). For a respirator mask to be approved, it has to go through the so-called “seal test”, simply a check that makes sure the mask appropriately adheres to the wearer’s face so that no particles of any sort filtrate within. On the other hand, masks for non-medical purposes are not medical devices and therefore are not regulated by the FDA.
This fairly long introduction (sorry about that, but it was necessary - duty before pleasure!) would not make sense if we did not give you any signs of a possible counterfeit respirator masks. Unfortunately, they exist, and are many. Let’s prevent each other from falling in this trap and spending way too much money for a low-quality product. Let us give you a hand! Before starting, we should clarify a term that you will find in the following list, that is NIOSH. NIOSH means National Institute for Occupational Safety and Health (mainly used in the US), and is a rating that describes the ability of a device to protect the wearer from dust and liquid droplets in the air. Well, now We think we got you covered. Let’s do this!
- No approval number on filtering facepiece respirator or headband
- No NIOSH markings
- NIOSH spelled incorrectly
- Presence of decorative fabric or other decorative add-ons (e.g., sequins)
- Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)
- Filtering facepiece respirator has ear loops instead of headbands
We know this talks about the US, but is more or less valid for the rest of the world too. The sense is always the same: for a face mask to be certified, the label should be clear, specific and easily readable and should explain the certification properly. They should comply with all the requirements of the MSU Respiratory Protection Program, which includes medical certification, training and annual fit testing.
If you would like to sell face coverings or supply them to others outside your household or family, the face coverings must meet the requirements of the 2005 General Product Safety Regulations (GPSR), which sets out the responsibilities of the producers and distributors of these products.
All in all, masks certifications are essential, and you need to be aware of it. We know it is a lot to take in, we went through some very technical stuff today. Boredom aside (hopefully, not much), we hope our point was clear: we all want to save money, and we work hard to do it so that we can go on vacation, shopping or we simply want to enjoy ourselves. That’s the beauty of life, isn’t it? However, we believe (and we wish you did too) health is far more important than wealth. Saving money sometimes does good, but some others, we don’t realize that a high-quality product is just some pence away. Don’t stop looking for it!
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