Tukes monitors the compliance of respirators by means of spot checks.
The information published in the Tukes Market Surveillance Register on 10 December 2021 concerning the withdrawal of respirators from the market has attracted widespread attention.
The Cambridge respirator was voluntarily withdrawn from the market and Xique branded respirator Tukes ordered its withdrawal.
The respirators withdrawn from the market were considered unsafe because they did not provide the promised protection efficacy with certainty. It is important for the safety of consumers that they are able to choose a protective device that is sufficiently effective for its intended use.
The FFP rating indicating the protection performance is affected by both the filtering capacity of the material and the overall leakage of the mask. Based on tests carried out in a laboratory in Denmark, these products did not meet the standard FFP2 requirements for overall leakage. In order for a product to reach FFP2, it must meet the criteria for both properties.
The overall leakage shall be tested by a test group selected from the group of persons familiar with the use of such or similar products. Therefore, the subjects are more experienced than the average consumer in assessing the fit of the respirator. The test subject evaluates the fit of the respirator on his/her face prior to the tests. If the subject feels that the respirator does not fit properly, he/she will not continue to test the respirator. This is to ensure that each subject tests only respiratory protective equipment, which he/she would think would protect himself/herself. There was total inward leakage in too many subjects. Therefore, the protective equipment only fulfilled the level of FFP1.