EU Safety Gate · Report-2020-52
PRIMA · Medical mask with two layers
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. The product does not comply with the requirements of the Medical Devices Directive and with the relevant European standard EN 14683.
- Published
- 25 December 2020
- Notifying authority
- Romania
- Catalog checked
- 30 July 2026
Check the authority measure and original alert.
Type of economic operator to whom the measure(s) were ordered: Retailer. Category of measure(s): Withdrawal of the product from the market. Date of entry into force: 04/11/2020
Official source alertProduct identification
- Safety Gate reference
- INFO/00182/20
- Batch
- LHP – 1283 02/2028
- Check-digit validated barcodes
- 6422125003911
Classification
- Category
- Protective equipment
- Risk type
- Health risk / other
- Country of origin
- People's Republic of China
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."