Indications and the requirements for single-use medical gloves

Abstract

While the requirements for single-use gloves for staff protection are clearly defined, the conventional medical differentiation between "sterile surgical gloves" used during surgical procedures and "single-use medical gloves" used in non-sterile medical areas does not adequately define the different requirements in these two areas of use. Sterilization of single-use medical gloves is not performed if sterility is not required; thus, another terminology must be found to identify the safety quality of non-sterile single-use medical gloves. Therefore, the labeling of such gloves should reflect this situation, by introducing the term "pathogen-free" single-use glove. The hygienic safety of such a glove would be attainable by ensuring aseptic manufacturing conditions during manufacturing and control of pathogen load of batch controls after fabrication. Proposed recommendation: Because single-use gloves employed in non-sterile areas come into contact not only with intact skin but also with mucous membranes, no potential pathogens should be detectable in 100 mL of rinse sample. In order to declare such gloves as pathogen-free we suggest absence of the indicator species S. aureus and E. coli. In addition, the total CFU count should be evaluated, since a high load indicates lack of optimal hygiene during the manufacturing process. Based on the requirements for potable water and findings obtained from investigations of the bacterial load of such gloves after manufacturing, the here suggested limit for the total bacterial count of <10(2) CFU/mL of rinse sample per glove seems realistic.

Keywords: definitions; indications; pathogen-free single-use gloves; requirements; single-use medical gloves; “germ-poor” single-use gloves.