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Certifications

    A Rich History of Quality Leadership

    Throughout our history, we have led the Indonesian disposable glove industry with our quality accomplishments, achieving the highest level of compliance with the world’s most respected quality organizations as well as regulatory clearances for the sale of medical devices in the United States and Europe, among other countries.

    Quality Certifications

    We have received numerous internationally recognized quality certifications and are proud to be the first Indonesian glove manufacturer to achieve EN 46002 and ISO 13485 certifications.

    In 2005, we upgraded our ISO 9001 and EN 46002 certifications to ISO 13485, the quality model for the global medical device industry that specifically addresses the unique quality and safety requirements of medical devices in addition to the basic requirements of ISO 9001.

    In keeping with our commitment to protect the environment around the world and our employees close to home, we have achieved the highly respected certifications for ISO 14001, Environmental Management Systems, and OHSAS (ISO) 18001 Occupational Health and Safety Management, a distinctions few in our industry have achieved.

     

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    Regulatory Clearances

    Our gloves meet or exceed the requirements of the US FDA receiving 510(K) clearances to market in the US and Europe’s Medical Device Directives MDD 93/42/EEC and CE marking. 

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    • ce

    International Testing Standards

    We comply with these additional international standards:

    • United States: ASTM D3577 / D6977 / D3578 / D6319
    • International / Europe:  EN 4551

      In addition, select Medisafe gloves have undergone additional advanced testing for:

    • ASTM D6978
    • ASTM F739
    • ASTM F1670
    • Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
    • Permeation of Chemicals through Protective Clothing Materials
    • Resistance to Synthetic Blood Penetration in Protective Clothing
    • ASTM F1671
    • EN455-3
    • EN374-3
    • EN1186
    • ASTM D7329
    • Resistance of Viral Penetration through Protective Clothing Materials
    • Biological Evaluation of Medical Gloves: Endotoxins
    • Resistance to Permeation by Chemicals
    • Migration of Food Contact Materials
    • Standard Specification for Food Preparation and Food Handling
    • 21 CFR 177.2600
    • ISO 10993-5
    • USP 26
    • GC/MS
    • Extractables for Food Handling (Food Service) Gloves
    • Biologic Evaluation of In Vitro Cytoxicity
    • Bacterial Endotoxins
    • Residual Chemical Levels in Finished Gloves

      Select gloves