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2020-09-15

Pandemic related product alerts | wk 37

Pandemic related product alerts | wk 37
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 last couple of weeks there have been no pandemic related product alerts published on Safety Gate. This week there is however a substansive list of particel filter masks. 

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 the brand 'JINLILAISI' (batchnumber 202000103). The country of origin of the product is China. Link to product alert
    The particle/filter retention of the material is insufficient (measured value ≤ 82.5%). 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.
    Measures ordered by public authorities (to: Other): Recall of the product from end users
  • The second product alert, a particle filter mask, is of the brand 'AH CHANGLI' (Batch number:  Production march 2020). The country of origin of the product is China. Link to product alert
    The particle/filter retention of the material is insufficient (measured value ≤ 88.8 %). 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 ordered by public authorities (to: Other): Recall of the product from end users
  • The next alert for a particle filter mask is of the brand 'KGT', with the name of the product 'TK 95 Atemschutzmaske' (Batch number:  Expiration Date: 05/2025, Production Date: 05/2020). The countruy of origin is Turkey. Link to product alert.
    The particle/filter retention of the material is insufficient (measured value ≤ 35 %) 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. This product does not comply with the Personal Protective Equipment Regulation and the relevant European standard EN 149
    Measures taken by economic operators: Withdrawal of the product from the market (By: Importer)
  • The fouth product alert for a particle filter mask is of the brand 'STEELPRO SAFETY'. The product bears the name '2740CV Respirador' (Barcode: 7798241796891). The country of origin is China. Link to product alert
    The product advertises a protective potential against particles but its filtering capacity has not been certified by a relevant body. Consequently, the product might not fulfill the health and safety requirements and thus not properly protect if not combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation.
    Measures taken by economic operators: Import rejected at border (By: Importer)
  • The next particle filter mask product alert of of an unknown brand, but bears the name 'KN95 Respirator/FFP2'. The country of origin is China. Link to product alert
    The product advertises a protective potential against (viral) particles but its filtering capacity has not been certified by a relevant (European) body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation.
    Measures taken by economic operators: Withdrawal of the product from the market (By: Distributor)
  • The last pandemic related product alert is of a particle filter mask of the brand 'Nan'an panda legend daily necessities Technology Co., Ltd'. The product bears the name 'Disposable protective mask FFP2' (Barcode: 897077100674). The country of origin is China. Link to product alert.
    The product bears a CE marking and advertises a protective potential against particles and microorganisms, but its filtering capacity has not been certified by a relevant body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional protective 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

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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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