Pandemic related product alerts - wk 30

Introduction

What do you need to ask when buying or producing face masks? What legislation is applicable to face masks? What are market surveillance authorities (MSA's) looking for? By analysing the weekly reposrt of Safety Gate we summarise for you what to look for. Products that don't cause hassle, ProductIP helps you!

If you are an economic operator* for these products, product recalls can help you make better products and prevent problems with market surveillance authorities. 

1. The first product is a particle filter mask from unknown brand (link to alert). The country of origin of the product is China.
   The particle/filter retention of the material is insufficient (measured value ≤ 89 %) and the mask does not properly adapt to the face. Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation. 
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. 
2. The second product is of the brand 'Allta'; a Particle filter mask (link to alert). The country of origin of the product is China.
   The mask does not properly adapt to the face. Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation.
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. 
3. The third product is a particle filter maks of the brand 'Bonwaye' (link to alert). The country of origin of the product is China.
   The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, the total filtration capacity of the mask is insufficient (measured mean value ≤ 79 %). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation.
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. 
4. The 4th product is a particle filter mask from unknown brand (link to alert). The country of origin of the product is China.
   The particle/filter retention of the material is insufficient (measured value ≤ 84 %). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation.
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. 
5. The 5th product is a particle filter mask from the brand 'VHC Gobal'. The country of origin of the product is China. (link to alert).
   The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, the particle/filter retention of the material is insufficient (measured value ≤ 93 %) and the mask does not properly adapt to the face, leading to an insufficient total filtration capacity (measured mean value ≤ 89 %). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation.
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. 
6. The 6th product is a particle filter mask from unknown brand, but with the name 'Máscara facial' (link to alert). The country of origin of the product is China.
   The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation. 
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. 
7. The next product is a particle filter mask from the brand '3 PLY', with the name 'Civil use disposable face mask'. The country of origin of the product is China (link to alert). 
   The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation.
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. 
8. The next product is a particle filter mask from the brand 'Non-woven.com', with the name 'Disposable face mask / Disposable protective mask (three layers)'. The country of origin of the product is China (link to alert).
   The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation.
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks.
9. The next product is a particle filter mask from the brand 'X.Y.T. Xiang Yan Tang', with the name of the product 'Non medical Disposable Mask'. The country of origin of the product is China (link to alert). 
   The visual inspection of the product reveals that its material composition, structure and shape are inappropriate. Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation. 
   Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks.
10. The 10th product alert is a particle filter mask from the brand 'PM Plus Medical' with the name of the product 'Protective Face Mask'. The country of origin of the product is China (link to alert). 
    The particle/filter retention of the material is insufficient (measured value ≤ 90.5 %) Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation and the relevant European standard EN 149.
    Measures ordered by public authorities (to: Distributor): Ban on the marketing of the product and any accompanying measures.
11. The last product alert of this week is another particle filter mask. The brand is 'Shengkun' and the name of the product is 'Disposable face mask'. The country of origin of the product is China (link to alert). 
    The product bears a CE marking and advertises a protective potential against particles and microorganisms, but its filtering capacity has not been certified as protective equipment by a relevant body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect when combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation. 
    Measures ordered by public authorities (to: Distributor): Ban on the marketing of the product and any accompanying measures.

More information

• Learn more on legislation filters masks and respitory devices must comply to by downloading the free ProductIP guide on this subject.
• Learn more on where to certify masks here. 

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* Economic operator means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation.