As the COVID-19 pandemic has persisted for over 2 years, wearing a mask has become a daily anti-epidemic routine for the public under the new normal. The filtration efficacy, comfort level, design and even the colour are all key decision factors when consumers purchase face masks. After the 2 previous tests in 2017 and 2020, the Consumer Council once again tested 30 models of single-use coloured/patterned face masks on the market. According to the test results, the average Bacterial Filtration Efficiency (BFE) and average Particle Filtration Efficiency (PFE) of all models reached 95% or above, equivalent to reaching the Level 1 requirement of the America Society for Testing and Materials (ASTM) F2100 Standard. However, despite all models being able to provide basic protection for the wearer in daily situations, over 60% (19 models) were found to have at least 1 sample with a PFE lower than claimed, reflecting that manufacturers still had much room for improvement in maintaining the quality of their products. Besides, individual models showed unsatisfactory performance in other test items. For example, the bioburden of 6 models exceeded the limit of colony forming unit set by the European Union (EU), 2 models had an unsatisfactory performance in the test on resistance to penetration by synthetic blood, some samples from 4 models had poorer breathability, while in the mask harness tension test, 7 models had at least 1 sample torn apart at a tension lower than the minimum requirement. Consumers should pay heed to the test results.
Under the Consumer Goods Safety Ordinance, consumer goods must comply with the “general safety requirements”, meaning that relevant manufacturers, importers and suppliers have the responsibility to ensure the consumer goods are reasonably safe. Otherwise, they may have committed an offence. If the product performance fails to comply with its claims, it might be in violation of the Trade Descriptions Ordinance. Despite “surgical masks” generally being considered as medical devices, Hong Kong currently has no specific legislation that regulates the manufacture, import, export, sale and use of medical devices. The Council advocates for heightening requirements for the quality of face masks as well as strengthening regulation. Not only would this help prevent the transmission of COVID-19, it could also lower the health risks posed to the public during influenza peak season each year.
The test covered 30 models of single-use surgical face masks of different colours and patterns, including 21 models of flat masks and 9 models of 3D masks, with an average retail price of $1.5 to $9.8 each. 28 of them claimed to be made in Hong Kong, while the remaining 2 claimed to be made in the Mainland. Amongst all models, 27 claimed to meet the requirements for ASTM F2100 Standard Level 3, while 3 were labelled as meeting Level 2 standard. Besides, 12 models simultaneously claimed to comply with the EU standard EN 14683 Type IIR. With reference to ASTM F2100, the test items of BFE, PFE, differential pressure (Delta P), and resistance to penetration by synthetic blood were included. In addition, the microbiological content and mask harness tension tests were conducted with reference respectively to the EU standard EN 14683:2019 and the China National Standard GB19083-2010 Technical Requirements for Protective Face Mask for Medical Use, whereas azo dye tests were conducted on the colours and patterns of the face masks, and the labelling information was also reviewed.
30 Models Had Satisfactory Overall Filtration Efficiency
The filtration efficiency of face masks is paramount. With reference to the ASTM F2100-19 requirements, the BFE and PFE must be at least 95% for Level 1, and be at least 98% for both Level 2 and Level 3. In the tests for both the BFE and PFE, 5 samples from each model were tested. The test result revealed that 29 models (97%) had an outstanding performance with an average BFE of over 99%. However, 1 model labelled as ASTM Level 3 was found to have a BFE lower than claimed (>99%) for all 5 test samples, ranging from 96.7% to 97.3%, only meeting the requirements of ASTM Level 1.
In the PFE test, 80% (24 models) performed satisfactorily with an average PFE of above 98%. Yet 19 models had at least 1 amongst their 5 test samples found with a PFE lower than claimed. The model with the greatest discrepancy claimed to have a PFE of >99%, but the actual measured average PFE was only 95.30%. Another model with a claimed PFE of ≥99% was found with an average PFE of 96.06% in the test, amongst which one of its samples had a measured PFE of 94.48%, which was even lower than the ASTM Level 1 requirement of 95%, falling short of expectations. Besides, the actual measured BFE and PFE of 1 model were both lower than claimed (>99%).
The test on resistance to penetration by synthetic blood simulated the splashing of blood or body fluid onto the mask surface to assess the protection efficacy of the face mask. Despite the relatively lower chance of encountering splashed blood or body fluids in daily life apart from certain occupations, this test still serves as practicable reference for the water resistance and leak resistance abilities of face masks. 32 samples of each model were put to test under corresponding pressure in accordance with their claimed standard level. If more than 3 samples were penetrated by synthetic blood at the lowest pressure of 80mmHg, that model’s performance would be rated as unsatisfactory. 63% (19 models) completely passed the test with excellent performance. However, in the test at the lowest pressure (80mmHg), 2 models performed poorly with 7 and 26 samples penetrated by synthetic blood respectively, and thus only scored 1 point in this test item.
Bioburden of 6 Models Exceeded Limit of EU Standard
During the pandemic, members of the public need to wear face masks for long hours both at school and at work to prevent infection or transmission of viruses. However, if the hygiene condition of the face mask itself is unsatisfactory, it might cause skin problems on the face. The performance of the face mask models in the bioburden test varied considerably. 6 models had detected bioburden levels (65.1 to >219.9) that exceeded the limit of 30 colony forming unit per gram set out in the EU standard EN 14683:2019. Amongst these, the model found with the highest bioburden even had a value that exceeded the limit by over 6 times, showing worrisome hygiene condition.
The comfort and breathability of face masks are also crucial. The test measured the difference in pressure in front of and behind the mask sample in order to evaluate the degree of breathability, which represents the level of comfort when breathing with a mask on. 80% (24 models) were detected with a pressure difference of lower than 5.0mmH2O/cm2, while that for 4 models was even lower than 3.0mmH2O/cm2 for all test samples, indicating better comfort and breathability. Amongst the 4 models with a lower level of comfort for breathing, some or all samples were measured with a pressure difference of over 6.0mmH2O/cm2, which did not meet the requirements for ASTM Level 2 and Level 3.
Past tests have revealed disparate quality for the ear straps of face masks. In the current mask harness tension test, over 20% (7 models) had at least 1 amongst the 4 test samples that was found to be lower than the lower limit (10N tension) of the National Standard. Amongst them, 3 models even had all 4 test samples torn apart at below 10N, meaning that the ear strap could snap more easily. The Council urges manufacturers to promptly rectify this issue, as the need to frequently change face masks not only wastes consumers’ money, but also causes wastage.
Face masks have become available in a wider variety of colours and patterns in recent years, allowing consumers to add a colourful touch to their daily life amidst the prolonged fight against the pandemic. In view of this, the Council also tested the models for carcinogenic azo dyes, so as to assess the safety of the dyes used in face masks. The results revealed that none of the models were detected with azo dyes and are safe for consumers to use.
Additionally, the Council also reviewed the labelling information of the products. It was found that the labelling information and user instructions for many models were not comprehensive enough, despite the importance of reminding consumers to take safety precautions in this persistent fight against COVID-19. The Council urges manufacturers to improve the labelling information, such as including reminders for correct steps before and after wearing a face mask, as well as stating the appropriate disposal method, etc.
Even while wearing face masks, consumers must not neglect other precautionary measures. They should always pay attention to personal and environmental hygiene and take note of the following:
- Check that the face mask is well-fitted with the face each time. This can be done by cupping both hands around the face mask, and checking for gaps at the outside edges. Ensure that there is no air leak at the edges near the eyes and at the sides of the mask;
- If the wearer cannot attain a snug fit using the above measures, they could knot and tuck the elastic ear loops where they join the edge of the face mask, then fold and tuck the excess material under the edges of the mask;
- If the face mask still cannot fit the face closely, the wearer could consider wearing an additional cloth mask on top of the surgical mask;
- Due to safety reasons, individuals with breathing difficulties or require assistance to remove their face masks, as well as unsupervised children under the age of 2, are recommended not to wear a face mask.
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