← All products
INFO/00180/20

Particle filter mask

Face Mask Surgical Disposable

Protective equipmentHealth risk / other
Country of origin
People's Republic of China
Notifying country
Romania
Sold online
No
Open the alert on the European Commission website ↗

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 of the relevant European standard EN 14683.

Measures taken

  1. Withdrawal of the product from the market Compulsory measuresTaken by: ImporterIn force from: 20 November 2020

Product

Description
Face mask surgical disposable.
Packaging
The masks are packed in a white and blue cardboard box containing 50 pieces with the product description in English with black characters. The packaging bears the CE marking.

Original source

Data comes from the official Safety Gate system of the European Commission.

Alert number
INFO/00180/20 ↗
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/10002583

Your reaction
Found a mistake? Let us know

Only the site administrator will see your message.