Low Dermatitis Potential of a Powder-Free, “Accelerator-Free” Non Natural Rubber Latex Gloves Using Modified Draize Study
- Author:
Maryam Sakinah Jeffrey
;
Wan Muhamad Aiman Wan Muhamad
;
Iman Jeffrey
;
Hanisah Jeffrey
;
Mardhiah Jeffrey
;
Muhammad Syafiq Muhammad Isa
;
Said AlGhora
;
Emad Ibrahim Husein Shaqoura
;
Doaa kamal Ibrahim Shaqoura
;
Sharifah Ismail
;
Nor Wajihan Muda
;
Siti Maryam Abdul Jabar
;
Saadiah Sulaiman
- Publication Type:Original Article
- Keywords:
Latex;
Allergy;
Nitrile;
Glove
- From:Malaysian Journal of Dermatology
2017;38(June):65-71
- CountryMalaysia
- Language:English
-
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”.
