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EU Safety Gate · Report-2021-20

Panodyne · Personal Face Mask N95

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

Published
21 May 2021
Notifying authority
Malta
Catalog checked
30 July 2026
What should you do?

Check the authority measure and original alert.

Type of economic operator to whom the measure(s) were ordered: Other. Category of measure(s): Recall of the product from end users. Date of entry into force: 04/05/2021

Official source alert
Safety Gate reference
A12/00690/21
Model
FBN95M-U
Batch
V001 19.03.2020
Check-digit validated barcodes
5060710519051
Category
Protective equipment
Risk type
Health risk / other
Country of origin
Not published

Face masks packed in individual labelled transparent plastic, in boxes of 50 Face masks with ear lugs marked (PM2.5 95 FFP2 Panodyne CE)