An assessment of the endotoxin contents of Natural Rubber latex medical gloves

The endotoxin levels of Malaysian Natural Rubber (NR) latex medical gloves were determined by a kinetic turbidimetric Limulus Amoebocyte Lysate (LAL) assay. The samples evaluated were 39 pairs of sterilised surgical gloves from 10 commercially-available brands and 21 pairs of non-sterilised examination gloves from 8 brands. The endotoxin concentrations ranged from 3.2 to 114.1 EU/glove pair for surgical gloves and from <8.4 to 9,632 EU/glove pair for the examination gloves. In the case of surgical gloves, 72% had endotoxin activity below the specified FDA standard of 20 EU/device, while in the case of the non-sterilised examination gloves, only 38% had values below the specified level. There was no correlation between endotoxin concentrations and the presence of glove powders in the present study.