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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

    In its pursuit for excellence and setting new standards for the global glove industry, Medisafe Technologies has demonstrated world-class standards for Environmental Management System, Occupational Health and Safety, Business and Social Compliance and Compliance to Product Safety.

    Medisafe Technologies has 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 February 2018, to keep our commitment in protecting the environment around the world and our employees close to home, we have achieved the latest versions and highly respected certifications for ISO 14001: 2015, Environmental Management Systems, OHSAS 18001:2007 Occupational Health and Safety Management, and HACCP for minimal chemicals and biological hazards, distinctions in which very few in our industry have achieved.

    In addition to the above, Medisafe Technologies also holds one of the best rating for Business Social Compliance Initiative (BSCI) compliance and for Ethical Trade Initiative (ETI).

    ISO 13485ISO 9001ISO 14001OHSAS 18001

    BSCI                    Sedex                 HACCP

    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. 

    • fda1
    • 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:

    • 21 CFR 177.2600
    • ASTM D3577
    • ASTM D6978
    • ASTM F739
    • ASTM F1670
    • ASTM F1671
    • Extractables for Food Handling / Food Service Gloves intended for repeated use
    • Standard Specification for Rubber Surgical Gloves
    • Resistance to Permeation by Chemotherapy Drugs
    • Resistance to Permeation of Liquids and Gases Under Conditions of Continuous Contact
    • Resistance to Penetration by Synthetic Blood through Protective Clothing Materials
    • Resistance to Viral Penetration through Protective Clothing Materials
    • EN 374-2
    • EN 374-3
    • EN 16523-1
    • EN 374-4
    • EN 420
    • EN 455-1
    • EN 455-2
    • EN 455-3
    • EN 1186
    • Resistance to Penetration Against Dangerous Chemicals and/or Micro-organisms
    • Resistance to Permeation by Chemicals
    • Resistance to Permeation by Chemicals
    • Resistance to Degradation by Chemicals
    • Protective Gloves – General Requirements and Test Methods
    • Testing for Freedom from Holes
    • Testing for Physical Properties
    • Testing for Biological Evaluation: Endotoxin
    • Testing for Overall Migration
    • ISO 374-1
    • ISO 374-5
    • ISO 10993-5
    • ISO 10993-10
    • PPE CAT III
    • USP 26
    • Part 1: Terminology and performance requirements for chemical risks
    • Part 5: Terminology and performance requirements for micro-organisms risks
    • Tests for In-vitro Cytotoxicity
    • Tests for Irritation and Skin Sensitization
    • Personal Protective Equipment Directive 89/686/EEC
    • Bacterial Endotoxins

    Select gloves