The Rapid Alert System for Non-Food Products (RAPEX)

Alert number: A12/01026/20

Product:  Particle filter mask

Name: Disposable protective mask

Barcode:  Unknown
Batch number:  Production Date: 2020.04.20, Production batch number: 2020.07

Type of alert: Serious

Category: Protective equipment

Brand: Isu

Type / number of model:  ISU-001

Counterfeit: NO

Risk type: Health risk / other
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.

Measures ordered by public authorities (to: Other): Import rejected at border

Description:  Protective respiratory filtration half-face mask according to EN 149.

Packaging description:  The product is sold in a white and blue cardboard box containing 50 pieces.

Country of origin: People's Republic of China

Alert submitted by: Belgium