Pandemic related product alerts, wk 29

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' 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 e a particle filter mask from the brand Isu (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 ≤ 88 %), the elastic cords of the mask easily detach and the mask does not properly adapt to the face leading to an insufficient total filtration capacity (measured mean value ≤ 39 %). 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.
   Import of the article is rejected at the border. The country of origin of the product is China.
2. The second product is another partilce filter mask. The brand is Gulibear (link to alert).
   The particle/filter retention of the material is insufficient (measured value ≤ 90 %) 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. The country of origin of the product is China.
3. The third product is another particle filter mask. The brand is 'XO Simple is beauty' (link to alert). 
   The particle/filter retention of the material is insufficient (measured value ≤ 86 %) 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. The country of origin of the product is China.
4. On number 4, also a particle filter mask. The brand is unknown (link to alert).
   The particle/filter retention of the material is insufficient (measured value ≤ 36 %) 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. The country of origin of the product is China.
5. On number 5, a particle face mask of the brand Zx (link to alert).
   The total filtration capacity of the mask is insufficient (measured mean value ≤ 59 %). 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. The country of origin of the product is China.
6. The next in line is a particle face mask of unknown brand (link to alert). 
   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. The country of origin of the product is China.
7. The last pandemic related alert is a particle face mask from the brand APT (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 ≤ 86 %) and the mask does not properly adapt to the face leading to an insufficient total filtration capacity (measured mean value ≤ 72 %). 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. The country of origin of the product is China.

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.