A Comparison of Type IV Hypersensitivity Reaction to Synthetic Polyisoprene Gloves versus Control Gloves Using Modified Draize-95 Test in Normal Individual

Abstract

Background: The emergence of epidemics in recent years, such as COVID-19 and monkeypox, has increased the need for protective gloves. Objectives: This study was performed to provide clinical evidence that no residual chemical additives are present in the powder-free, non-latex, with and without pigment, sterile and non-sterile nitrile, and polyisoprene gloves at a level that may induce type IV allergy in the unsensitized general user population. Methods and Materials: We conducted the modified Draize-95 test on the GAMMEX® Non-Latex PI, sterile powder-free synthetic polyisoprene surgical gloves (S01) and the GAMMEX® Non-Latex PI Green, sterile powder free synthetic polyisoprene surgical gloves (S02). A quasi-experimental non-equivalent study consisted of 180 healthy unsensitized adult volunteers at the Islamic University of Gaza. Participants were divided into two groups: 150 white subjects and 30 black subjects. Each group divided into two groups, each one contained approximately the same numbers of males and females. We used two sets of different test materials as 2x2 cm pieces of the glove's materials from the inner and outer surfaces mounted on an adhesive patch. For the control groups, we used Nitrile Skin Examination Powder-Free Disposable Gloves (C1) and Aegis Examination Gloves (C2). Results: None of the participants showed positive reactions to the test materials of equal or greater than 1.5 in the challenge or rechallenge phase, both on the inner and outer surfaces of the GAMMEX® Non-Latex PI, sterile powder-free synthetic polyisoprene surgical gloves (S01), and the GAMMEX® Non-Latex PI Green, sterile powder-free synthetic polyisoprene surgical gloves (S02). Only one white woman showed a reaction to the inner surface of the S02 material in the induction phase. Three participants showed skin reactions to the second control material, the Aegis Nitrile Examination Gloves (C2). Those three were a white female in the induction phase and two white males in the challenge phase. However, none of them showed any reaction later. Conclusion: The modified Draize test negative results for the GAMMEX Non-Latex PI, sterile powder-free, synthetic polyisoprene surgical gloves (white and green) support the claim that the chemical sensitization potential of these materials is low and that no residual chemical additives are present in these gloves at a level that could cause type IV hypersensitivity reactions.