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A12/00690/21

Particle filter mask

Panodyne · Personal Face Mask N95

Protective equipmentHealth risk / other
Notifying country
Malta
Open the alert on the European Commission website ↗

What is the danger

The product bears a CE marking but its filtering capacity has not been tested by a relevant competent European conformity assessment body. Additionally, the particle/filter retention of the material is insufficient (measured values: as low as 39%), the total filtration capacity of the mask is insufficient (measured mean values: as low as 75%). Consequently, the product does not fulfil the health and safety requirements; thus, even if combined with other recommended measures, it may not properly protect.

Requirements breached

The product does not comply with the Personal Protective Equipment (PPE) Regulation and with the relevant European standard EN 149.

Measures taken

  1. Recall of the product from end users Compulsory measuresTaken by: OtherIn force from: 4 May 2021

Product

Description
Face masks packed in individual labelled transparent plastic, in boxes of 50 Face masks with ear lugs marked (PM2.5 95 FFP2 Panodyne CE)
Packaging
Face masks packed in individual labelled transparent plastic, in boxes of 50 with dimensions of 200x100x100mm/box
Brand
Panodyne
Model / type
FBN95M-U
Barcode
5060710519051
Batch
V001 19.03.2020

Original source

Data comes from the official Safety Gate system of the European Commission.

Alert number
A12/00690/21 ↗
Weekly report
Report-2021-20
Published
20 May 2021
Modified
20 May 2021

© European Union, Safety Gate · https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10003686

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