EU alert · Safety Gate Risk: Other types of alerts Protective equipment
Medical face mask “Medical Sterile Mask” — risk: health risk / other
Published in the Safety Gate weekly report: · Ref. INFO/00117/20
Summary
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.
A Safety Gate alert means that national authorities found a serious or relevant risk and took measures. The same product may also be sold under other names or online.
Product
Medical face mask
- Name / model
- Medical Sterile Mask
- Barcode
- EAN 6954295425540
- Category
- Protective equipment
- Medical face mask
What is the risk?
- 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.
Measures taken
- Type of economic operator to whom the measure(s) were ordered: ImporterCategory of measure(s): Import rejected at border
- Date of entry into force: 03/04/2020
Photos
Source: Safety Gate — European Commission
Data and images: Safety Gate, © European Union, licensed under CC BY 4.0. EU Safety Radar is an independent information service; the text above is an editorial presentation of the official data — the entry in the source system is authoritative.
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