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Quality Standards

Isoprene surgical gloves comply with these international standards:

  • International: ISO 13585 Quality System
  • United States:  FDA Quality System Regulation (QSR), ASTM D3577
  • EU:  Medical Device Directives 93/42/EEC, EN 455

 

In addition, the gloves have undergone additional advanced testing:

  • Penetration Resistance to Blood Borne Pathogens (ASTM F1671)
  • Biological Evaluation of Endotoxin Level  (EN 455-3)
  • Chemical Permeation Resistance to Industrial Chemicals (EN 374-3)
  • Permeation Resistance to Cytotoxic Chemotherapy Drugs (ASTM D6978)