title: Biaxial flex-fatigue and viral penetration of natural rubber latex gloves before and after artificial aging.
abstract: Barrier integrity of unaged and oven-aged (at 70 degrees C) natural rubber latex examination gloves was assessed with a biaxial flex-fatigue method where failure was detected electronically, and by live viral penetration testing performed according to a modified version of ASTM F1671-97a. When no change in barrier properties was detected during flex testing, no virus passage was found after viral challenge. Conversely, when a change in the barrier properties was indicated by the electrical signal, virus passage was found in 74% of the specimens. Flex-fatigue results indicated that unaged test specimens from powdered (PD) and powder-free (PF) nonchlorinated gloves had significantly longer fatigue lives than powder-free chlorinated (CL) gloves from the same manufacturer. Biaxial flexing of oven-aged glove specimens showed a marginal increase in fatigue life for the PF gloves, but no increase for the PD gloves. The fatigue life of the CL gloves was observed to increase significantly after oven aging. However, this appears to be due to a design feature of the test apparatus, wherein peak volume displacement of the worked specimen is held constant. An aging-induced change in the viscoelastic properties of the CL gloves-permanent deformation of the specimens early in the fatigue test-relieves the stress magnitude applied as the test progresses. Thus, permanent deformation acts as a confounding factor in measuring durability of latex gloves by fixed displacement flex-fatigue.
authors.affiliation: Office of Science and Technology (HFZ-150), Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, Maryland 20852, USA. mrs@cdrh.fda.gov
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Schwerin
authors.forename: Donna L
authors.initials: DL
authors.lastname: Walsh
authors.forename: D
authors.initials: D
authors.lastname: Coleman Richardson
authors.forename: Richard W
authors.initials: RW
authors.lastname: Kisielewski
authors.forename: Richard M
authors.initials: RM
authors.lastname: Kotz
authors.forename: Licia B
authors.initials: LB
authors.lastname: Routson
authors.forename: C
authors.initials: C
authors.lastname: David Lytle
mesh_terms: D010584:Bacteriophage phi X 174 / Q000302:isolation & purification; D001672:Biocompatible Materials; D017606:Chlorine Compounds; D017575:Gloves, Protective / Q000009:adverse effects* / Q000821:virology*; D006358:Hot Temperature; D006801:Humans; D066298:In Vitro Techniques; D008422:Materials Testing; D011208:Powders; D012408:Rubber; D013314:Stress, Mechanical; D013997:Time Factors
chemical_list: D001672:Biocompatible Materials; D017606:Chlorine Compounds; D011208:Powders; D012408:Rubber