Particle filter mask
PRIMA · Medical mask with two layers
- Country of origin
- People's Republic of China
- Notifying country
- Romania
- Sold online
- No
What is the danger
The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such 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.
Requirements breached
The product does not comply with the requirements of the Medical Devices Directive and with the relevant European standard EN 14683.
Measures taken
- Withdrawal of the product from the market Compulsory measuresTaken by: RetailerIn force from: 4 November 2020
Product
- Description
- Green medical mask with two layers. Masks are described as Class 1 medical devices, but in the same time, as ,,General purpose face mask suitable for medical, food processing as well as industrial use."
- Packaging
- The product is sold in a white and blue cardboard box containing 50 pieces.
- Brand
- Barcode
- Batch
Original source
Data comes from the official Safety Gate system of the European Commission.
- Alert number
- INFO/00182/20 ↗
- Weekly report
- Report-2020-52
- Published
- 24 December 2020
- Modified
- 24 December 2020
© European Union, Safety Gate · https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10002572
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