EU Safety Gate · Report-2021-12
ELIS SHPK, myfixmask · N95/FFP2 respirator, N95/FFP2 mask
The particle/filter retention of the material is insufficient (measured value as low as 49%). 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. As a result of the labelling, the mask may be worn in areas where hazardous substances are in use or during activities involving asbestos; since the mask fails to offer sufficient protection, this could lead to asbestosis, with fatal consequences. The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.
- Published
- 26 March 2021
- Notifying authority
- Germany
- Catalog checked
- 30 July 2026
Check the authority measure and original alert.
Type of economic operator to whom the measure(s) were ordered: Other. Category of measure(s): Destruction of the product. Date of entry into force: 15/02/2021 · Type of economic operator to whom the measure(s) were ordered: Other. Category of measure(s): Marking the product with appropriate warnings on the risks. Date of entry into force: 01/02/2021 · Type of economic operator taking notified measure(s): Importer. Category of measure(s): Import rejected at border. Date of entry into force: 01/02/2021
Official source alertProduct identification
- Safety Gate reference
- A12/00418/21
- Model
- 001, 002
Classification
- Category
- Protective equipment
- Risk type
- Health risk / other
- Country of origin
- Not published
Product description
Protective respiratory filtration half-face mask. Models 001 and 002 cannot be distinguished from each other on the basis of the printed labelling or the barcodes. Furthermore, the masks' labels differ from one mask to another and are not uniform. The product is also sold online.