Official safety alertOther types of alerts
EU Safety Gate · Report-2020-33
Medical Sterile Mask
The product claims to meet the requirements of a surgical mask but it has not been certified as such by the 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 of the relevant European standard EN 14683.
- Published
- 14 August 2020
- Notifying authority
- Poland
- 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): Import rejected at border. Date of entry into force: 03/04/2020
Official source alertProduct identification
- Safety Gate reference
- INFO/00117/20
- Check-digit validated barcodes
- 6954295425540
Classification
- Category
- Protective equipment
- Risk type
- Health risk / other
- Country of origin
- People's Republic of China
Product description
Medical face mask