DISPOSABLE FACE MASKS
| Alert Number | A11/00016/21 |
| Brand | ELMED |
| Category | Protective equipment |
| Risk Type | Health risk / other |
| Notifying Country | Romania |
| Country of Origin | Türkiye |
| Model Number | TP-MSK-013 (Non Sterile) |
| Published | 5 March 2021 |
Risk Description
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.
Measures Taken
Type of economic operator to whom the measure(s) were ordered: ImporterCategory of measure(s): Ban on the marketing of the product and any accompanying measuresDate of entry into force: 27/10/2020
Product Description
Non-medical disposable protective mask, 3 layers of protection.