ASTM D5151-19 Analysis

ASTM D5151-19 describes a test method for determination of holes in gloves.¹⁵ This method was used to evaluate all gloves. The full procedure can be accessed via ASTM and is only briefly outlined here, along with any notable deviations.

The gloves were placed on the mandrel of the water leak test apparatus and secured with a tight-fitting O-ring (Figure 1). Up to five gloves could be fitted to the apparatus at a time. While fitted, they remained suspended with the opening of the glove facing upward and the fingers pointed down. Room temperature water (1 L) then was dumped into the glove all at once by the apparatus. The investigator then inspected each glove for sweating (where small beads of water pushed through the glove) and for punctures (where water rapidly leaked through the glove in a stream). If a glove leaked or sweated, it was denoted as a failure to meet the standard.

ASTM D5151-19 glove tester fitted with five gloves for analysis.

As outlined in ASTM D3577-19¹⁶ and ASTM D3578-19,¹⁷ the sample size of gloves to determine the acceptable quality level (AQL) depends on lot size. However, we were unaware of the lot size, and the method of testing five gloves for each decontamination cycle falls well below any meaningful number of gloves in establishing an AQL of 1.5% for surgical glove or 2.5% for examination gloves.

Generally, all gloves leaked on the palm and fingers, with small beads forming at the failure site and slowly “weeping” except the nitrile examination gloves when treated with ABHS. This combination demonstrated significant tearing prior to removal from the investigator's hands (Figure 2). Of note, the doffing and donning of gloves (the bleach and quat samples), as compared with leaving gloves on the investigator's hands (washing with soap and water and ABHS), may have influenced the results. This was separated for a couple of reasons. First, failure of glove on an investigator's hands while using a more caustic solution (bleach or quat) was anticipated and deemed an unacceptable risk. This is why mannequin hands were used. Leaving gloves on the investigator's hands (washing with soap and water and ABHS) and anticipation of failure did not expose the investigator to unacceptable risk. Second, the situation in which gloves remained on the investigator's hands better mimicked the scenario of extended use during supply crisis, when gloves would remain on HCPs' hands.⁵

Although the nitrile examination gloves maintained their integrity after three treatments with alcohol-based hand sanitizer (ABHS), significant tears in the gloves began to occur after six treatments with ABHS.