• A RELIABLE SOLUTION
    THAT YOU CAN TRUST

    LOW DERMA™ enhanced nitrile gloves comply to
    International Standards and supported by various testing.

    MEDICAL CLAIMS

    Low Dermatitis Potential
    Tested for Used with 15 Chemotherapy Drugs

    COMPLIANCE TESTS FOR MEDICAL APPLICATIONS

    • Clinical Test (Modified Draize-95' on 200 Human Subjects)
    • Biological Evaluation (ISO 10993-5, ISO 10993-10)
    • Chemotherapy Drugs Permeation (ASTM D6978)
    • Viral Penetration (ASTM F1671)
    • Test Certificate by External Lab (ASTM D6319)
    • Test Certificate by External Lab (EN 455-1/2/3)
    • Shelf Life Study (EN 455-4, ASTM D7160)
    • Chemical Residue (Chromatography Analysis)
    • Chemical Sensitivity Assay (ASTM D7558)

    PPE CLAIMS

    PPE CAT III

    COMPLIANCE TESTING FOR NON-MEDICAL PPE APPLICATIONS

    • General requirement for protective gloves (EN420)
    • Resistance to Penetration (EN 374-2)
    • Chemical Permeation test (EN 16523-1)
    • Chemical Degradation Test (EN 374-4)
    • Protection against viruses, bacteria and fungi (EN ISO 374-5)
    • Conformity to type based on quality assurance of the production process (Article 11B/Module D)

    FOOD HANDLING CLAIMS

    21 CFR 177.2600
    ISEGA

    COMPLIANCE TESTING FOR FOOD HANDLING APPLICATIONS

    • Extraction test per US FDA 21 CFR 177.2600
    • ISEGA Food Contact Certification – in compliance with
      1. EC 1935/2004
      2. Foodstuffs and Animal Feed Code (LFGB)
      3. EU10/2011, and
      4. German Recommendation XXI

    HAZARDOUS CHEMICAL COMPLIANCE

    COMPLY TO

    • Proposition 65, California Drinking Water & Toxic Enforcement Act 1986
    • REACH, European Chemicals Agency (ECHA)
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