The four alerts, published on Tuesday on the DGC website, reveal the “insufficient” particle / filter retention of four products that increase the risk of infection if additional protective measures, such as social detachment, are not used.
The DGC banned the marketing of one of the products, ordered the destruction of another and issued warnings about the risks to the health and safety of users on the remaining two.
The four products subject to alert are the self-filtering respiratory protection masks of the model FFP2 KN 95, model KN 95, model YK01 FFP2 and the brand JY.M9.
The self-filtering respiratory protection mask YK01 FFP2, notified under the Safety Gate - RAPEX (Rapid alert system for dangerous non-food products), with nasal clip and elastic tapes to secure it behind the ears, sold in a cardboard box containing 20 units, originating in China, bears the CE marking but is not certified as protective equipment by a notified body.
DGC also says that the retention of particles in its filtering material is insufficient, with a measured value of 68,5% and, consequently, if other protective measures are not added, “an excessive amount of particles or microorganisms can pass through mask, increasing the risk of infection ”, and the order to destroy the product was given.
Also the technical defect of the JY.M9 brand product, sold in a cardboard box containing 50 units of masks, is the insufficiency (measured value equal to 59%) in the retention of particles in the filtering material, also increasing the risk of infection, and the measure adopted was a warning to consumers about the risks.
In this product the origin is unknown, but also in the self-filtering respiratory protection mask "model FFP2, KN 95", sold in a cardboard box containing 20 units, the origin is also from China and the retention of particles in the filter material is even more insufficient, of 53%, causing an increased risk of infection, with the decision to prohibit the sale of the product and possible accompanying measures.
The self-filtering respiratory protection mask KN95, category FFP2 according to the European standard EN 149, also has insufficient particle retention in the filter material (measured value equal to 90%) and, consequently, according to DGC, if not other protective measures are added, “an excessive amount” of particles or microorganisms can pass through the mask, increasing the risk of infection, and the measure to warn consumers about the risks has been decided.
In addition to these four alerts on August 04, two weeks earlier, on July 13, another alert on masks was advertised by DGC, for several batches of the KN95 product of the NEP brand, from China and sold in a cardboard box containing 50 units, and whose technical defect is also the retention of particles in the filtering material with a measured value of 62%.
As a measure adopted, DGC announces the collection of the product from consumers and, as in all alerts it publishes, it remembers to be the national contact point of the “Safety Gate - RAPEX”, transmitting the information to the national market surveillance authorities .
In April, when the use of masks in the community started to be recommended when there is a high number of people in an enclosed interior space, the Directorate-General for Health (DGS) issued an information warning about the need for the use of that equipment “to imply the knowledge and mastery of the techniques of placement, use and removal ”, and that their use cannot lead to the neglect of measures that they consider fundamental, such as social distance and hand hygiene.