Assessment of the skin sensitizing potential of pandemic-associated medical devices using the GARDskin Medical Device assay

Joint poster with Essity Hygiene & Health AB,
Presented at the 2021 Eurotox annual meeting

P. Mohlin, A. Forreryd, O. Larne, R.-M. Jenvert, H. Johansson | Essity Hygiene & Health AB, Product Safety, Clinical & Regulatory Affairs, Mölndal, Sweden; SenzaGen AB, 22381 Lund, Sweden

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  • GARDskin is well adapted to risk assess the skin sensitizing potential of medical devices in accordance with ISO 10993.
  • GARDskin Medical Device classified the tested commercially available face masks as non-sensitizers and the nitrile glove as sensitizers.
  • New in vitro technologies, like GARD, is well suited as a routine tool to increase the speed of decision making in extraordinary situations as a pandemic.


The current SARS-CoV-2 pandemic have led to an increased use of medical devices such as face masks and nitrile gloves, within occupational groups of medical care as well as within the general population. Consequently, the incidence reports of adverse effects associated with use of such medical devices have increased manyfold, including reports of allergic skin reactions.

The cause of allergic skin reactions, referred to as Allergic Contact Dermatitis (ACD) is the immunological process known as skin sensitization, which is induced by so-called chemical sensitizers. Assessment of skin sensitizing potential of leachables from medical devices is a part of biocompatibility testing of medical devices and is typically performed by use of the Guinea Pig Maximization Test (GPMT), in accordance with the ISO 10993 series of standards. However, recent developments of in vitro assays for assessment of chemical sensitizers motivates the exploration of such methods in the context of rapid pandemic-associated testing.

The GARDskin assay [1] is a next-generation in vitro assay for hazard assessment of skin sensitizers, currently progressing towards regulatory acceptance. The method evaluates the transcriptional patterns of a genomic biomarker signature in a human dendritic-like cell line following exposure, in order to provide hazard assessments of tested substances. The method has been adapted to testing of solid materials from e.g. medical device products, by application of extraction protocols using polar- and non-polar extraction vehicles, in accordance with ISO 10993-12.

Here, we present results from testing of a commonly used face mask and a nitrile glove in the GARDskin Medical Device assay. Results indicate that the face mask does not leach any compounds with skin sensitizing potential (among four different batches tested), while the nitrile glove was classified as a skin sensitizer. These results harmonize with preexisting experience of similar models of nitril gloves, which are known to be associated with adverse skin reactions, potentially induced by skin sensitization. Furthermore, these results may have implications on the continued use of similar medical devices throughout the pandemic and beyond, as the appropriate application and removal of face masks may indeed benefit from the discontinued simultaneous use of nitrile gloves.