SAFETY GATEReference A12/01580/21
priuMask — health risk / other
Descriptive title organised by NagameAlert; the official wording is available from the source.
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- priuMask
- Brand
- PRINTEXMedical
- Category
- Protective equipment
- Lot/s
- 21.12.2020
- Product domain
- Non-foodNagameAlert treatment
Official information
Risk and measures
- Risk or hazard
- Health risk / other
- Official description
- The particle/filter retention of the material is insufficient (measured values: as low as 84%). Furthermore, the mask may lack a nose clip, therefore it cannot be correctly adapted to the user's face. Consequently, the product does not fulfil the health and safety requirements; thus, even if combined with other recommended measures, it may not properly protect. The product does not comply with the Personal Protective Equipment (PPE) Regulation and with the relevant European standard EN 149.
- Measures
- Type of economic operator to whom the measure(s) were ordered: OtherCategory of measure(s): Ban on the marketing of the product and any accompanying measuresDate of entry into force: 26/08/2021Type of economic operator to whom the measure(s) were ordered: OtherCategory of measure(s): DIN EN 149: Respiratory protective devices – Filtering half-masks to protect against partDate of entry into force: 26/08/2021Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Enclose required documentsDate of entry into force: 26/08/2021Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Destruction of the productDate of entry into force: 26/08/2021Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: 26/08/2021
Territory
Geography
- Notifying country or territory
- Germany
- Distribution
- Notificado por Germany
Provenance and context
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