STP1133: Ability of 1000 mL Water Leak Test for Medical Gloves to Detect Gloves with Potential for Virus Penetration

    Kotilainen, HR
    Faculty membersResearch scientistsDirectorBiologist, University of Massachusetts Medical CenterFDA Center for Devices and Radiological HealthBaxter Healthcare Corp.Biocon, Inc., WorcesterRockvilleValenciaRockville, MAMDCAMD

    Cyr, WH
    Faculty membersResearch scientistsDirectorBiologist, University of Massachusetts Medical CenterFDA Center for Devices and Radiological HealthBaxter Healthcare Corp.Biocon, Inc., WorcesterRockvilleValenciaRockville, MAMDCAMD

    Truscott, W
    Faculty membersResearch scientistsDirectorBiologist, University of Massachusetts Medical CenterFDA Center for Devices and Radiological HealthBaxter Healthcare Corp.Biocon, Inc., WorcesterRockvilleValenciaRockville, MAMDCAMD

    Gantz, NM
    Faculty membersResearch scientistsDirectorBiologist, University of Massachusetts Medical CenterFDA Center for Devices and Radiological HealthBaxter Healthcare Corp.Biocon, Inc., WorcesterRockvilleValenciaRockville, MAMDCAMD

    Routson, LB
    Faculty membersResearch scientistsDirectorBiologist, University of Massachusetts Medical CenterFDA Center for Devices and Radiological HealthBaxter Healthcare Corp.Biocon, Inc., WorcesterRockvilleValenciaRockville, MAMDCAMD

    Lytle, CD
    Faculty membersResearch scientistsDirectorBiologist, University of Massachusetts Medical CenterFDA Center for Devices and Radiological HealthBaxter Healthcare Corp.Biocon, Inc., WorcesterRockvilleValenciaRockville, MAMDCAMD

    Pages: 11    Published: Jan 1992


    Abstract

    Does the 1000 mL water leak test for medical gloves detect potential for virus penetration? Water leak and virus penetration were determined sequentially in hanging latex surgical gloves (4 brands) with 1000 ml of ΦX174-containing buffered saline (DPBS). Individual fingers (some punctured) were visually examined for water (DPBS) leaks for 2 minutes, then dipped into DPBS for 60 minutes for collection of virus that penetrated the latex barrier. Many punctured and a few non-punctured fingers leaked both water and virus. Some punctured fingers did not leak water nor virus. A few of the control and punctured fingers that did not leak water did allow very low-level virus penetration by 1 hour; 4–50 fold lower than virus penetration from barely-detectable water leaks. Thus, a few gloves with potential for very low-level virus penetration were not detected by the 1000 mL water leak test.

    Keywords:

    medical gloves, standard test, water leak, virus penetration, puncture


    Paper ID: STP19149S

    Committee/Subcommittee: F23.96

    DOI: 10.1520/STP19149S


    CrossRef ASTM International is a member of CrossRef.