EU Safety Gate · Report-2021-9
ELMED · DISPOSABLE FACE MASKS
The product bears a CE marking but is not certified as protective equipment by a relevant body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. Also, the labeling is confusing because on the cardboard box the mask is declared a “non-medical” one , while in the same time is mentioned the standard EN 14683: 2019. The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.
- Published
- 05 March 2021
- 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: Importer. Category of measure(s): Ban on the marketing of the product and any accompanying measures. Date of entry into force: 27/10/2020
Official source alertProduct identification
- Safety Gate reference
- A11/00016/21
- Model
- TP-MSK-013 (Non Sterile)
- Batch
- TMSK013-2033
- Check-digit validated barcodes
- 8681371811345
Classification
- Category
- Protective equipment
- Risk type
- Health risk / other
- Country of origin
- Türkiye
Product description
Non-medical disposable protective mask, 3 layers of protection.