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Quality Standards

Our Nitrile gloves conform to these international standards:

  • International: ISO 13485 Quality System,  ISO 10993
  • United States: FDA Quality System Regulation, ASTM D6319
  • EU: Medical Device Directives 93/42/EEC, EN 455 *

In addition, many of our Nitrile gloves have undergone additional advanced testing * :

  • Chemical Permeation Resistance to Industrial Chemicals (EN 374/ASTM F739)
  • Permeation Resistance to Cytotoxic Chemotherapy Drugs (ASTM D6978)
  • Migration Testing for Contact Food Materials (EN 1186/ ASTM D7329)
  • Extractables for Food Handling (21 CFR 177.2600)
  • Resistance to Viral Penetration in Protective Clothing (ASTM F1671)
  • Resistance to Synthetic Blood Penetration in Protective Clothing (ASTM F1670)

Our gloves are certified Kosher and Halal and meet the strict manufacturing standards set for these certifications.

* Select gloves. Please contact our Sales Specialists for details.