The European medical glove industry follows strict regulations to ensure a high degree of safety for both healthcare workers and patients, with several standards ensuring manufacturers produce gloves that comply with the necessary health and safety requirements.
Despite quality being an important criterion for medical glove acceptance in Europe, concern is increasing about the influx of non-compliant examination gloves into the market, especially during the COVID-19 outbreak.
A recent Frost & Sullivan study shows that only nine of the 22 glove brands examined (40%) passed the BS EN455-1 and BS EN455-2 standards, where perforation and force at break (FAB) are the main non-compliance contributors. These results are alarming and require glove importers’ and regulators’ attention to ensure manufacturer quality adherence.
Key Takeaways
- Most glove brands (77%) complied with the perforation standard for examination gloves at an acceptable quality limit (AQL) of 1.5%. However, some glove brands claim the lowest AQL of 0.65%, as stated on their packaging, but did not even pass the 1.5% AQL. This information misleads consumers, making them think they are purchasing better quality gloves, for which they are willing to pay more.
- More than half of the glove brands (12 brands or 55%) failed FAB testing, with most scoring below the required mark for both challenged and unchallenged.
- Considering dimensions, all glove brands fulfilled the standard requirement for width, while only 2 brands (9%) failed to meet the minimum length limit.
- Despite common belief, a glove’s weight or thickness (cuff, palm, and finger) is not an accurate indicator of its quality. While Brand B and Brand V are among the 5 lightest and 5 thinnest (for most areas), both fully complied with BS EN455-1 and BS EN455-2 standards. In contrast, although Brand F is one of the heaviest and thickest glove brands, it failed most of the BS EN455 standards the study evaluated.
Glove importers, regulators, or enforcement agencies do not usually check compliance with medical glove standards for product batches nor periodically while the CE certification is still active. As such, a risk exists for an influx of inferior products into the market, especially when demand for medical gloves is high (for example, at the beginning of the COVID-19 pandemic) or with a change in contract manufacturer. Glove importers, regulators, or enforcement agencies must consider this trend and ensure to monitor the quality of medical gloves entering the market.
Read more in our white paper, Nitrile Examination Gloves in Europe, here.
