ABSTRACT
Introduction: The escalated demand for protective rubber glove in the healthcare industries has resulted in increased prevalence of glove related skin problem, irritant and allergic contact dermatitis and latex sensitivity. The industry has recently introduced a new nitrile glove product using a novel patented non-sulphur system to effect co-valent bond crosslinking to provide the desired elasticity of the gloves. This glove also has ionic crosslinking provided by the zinc oxide used in the formulation and the carboxylic group of the nitrile latex. The main objective of this study is to prove that residual chemical additives at a level that may induce Type IV allergy in the unsensitized general user population are not present in this rubber glove and to compare it with a powder free latex examination glove. Methods: In collaboration with the Islamic University of Gaza, we conduct modified test on a specially formulated and powder free, accelerator free LOW DERMA™ enhanced nitrile rubber glove that has physical properties and barrier integrity similar to that of NRL gloves. This glove does not contain sulphur or sulphur related compound. Two sets of Powder free, accelerator free LOW DERMA™ Nitrile Patient Examination Gloves*, white and blue colour were tested using the modified draize-95’ test. Filter paper soaked in normal saline and powder free latex examination glove were used as control. Results: A total of 209 subjects, 149 subjects, Caucasian (71.29%), 30 subjects, Afro Caribbean (14.35%) and 30 subjects, Asiatic (14.35%) were recruited. All 209 subjects had a final patch testing scoring of not more than 1.5 during both the induction phase and the challenge phase for both types of Powder Free Nitrile Patient Examination Gloves (white and blue) and to the negative control, normal filter paper and the powder free NRL control glove. Conclusion: The skin sensitization test (‘Modified Draize-95’ Test) of Powder Free Nitrile Patient Examination Gloves (white and blue) and the powder free NRL examination glove were negative. There was no clinical evidence on the presence of residual chemical additives at the level that may induce Type IV allergy in unsensitized general user population for both Powder Free Nitrile Patient Examination Gloves, blue and white colored, non-sterile. Both gloves qualify for “Low dermatitis Claim”.