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2020-11-06

Pandemic related product alerts | wk 45

Pandemic related product alerts | wk 45
Regulatory

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!

 

The product alerts publsihed here are always published on Safety Gate: the rapid alert system for dangerous non-food products

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

  • The first particle filter mask is of unknown brand, Barcode: 25404014515403. The country of origin is China. Link to product alert
    The total filtration capacity of the mask is insufficient (measured mean value ≤ 72,90 %), 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 and with the relevant European standard EN 149.
    Measures ordered by public authorities (to: Importer): Recall of the product from end users
  • The second pandemic related product alert is another particle filter mask of the brand 'Supernal' (Type / number of model:  GB/T 32610-2016). Link to product alert.  
    The mask is presented as providing a high protective function (“high filtration capacity”, “help filter up to 90% of bacteria”, “ideal for home healthcare use”). However these claims are not backed by evidence. In the absence of proof of the efficiency of these masks, this could create a false sense of safety to the wearer of the mask” and thus not properly protect if not combined with additional measures. 
    Imprt of the masks was rejected at the border.

More information

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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.

 


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