• Medisafe ConnectTM
  • Employee Portal
Medisafe
  • Home
  • About|
    • Chairman’s Welcome
    • Why Choose Medisafe
    • Markets We Address
    • Focus on CSR
  • Product|
    • Overview
    • Nitrile
    • Polychloroprene
    • Isoprene
  • Process|
    • Manufacturing and Quality
    • Our Innovation
    • Certifications
  • Resources|
    • Overview
    • Industry News
    • Industry Links
    • Knowledge Center
    • Glossary
  • Join Us|
    • Career Opportunities
  • Contact
Medisafe
  • Home
  • About|
    • Chairman’s Welcome
    • Why Choose Medisafe
    • Markets We Address
    • Focus on CSR
  • Product|
    • Overview
    • Nitrile
    • Polychloroprene
    • Isoprene
  • Process|
    • Manufacturing and Quality
    • Our Innovation
    • Certifications
  • Resources|
    • Overview
    • Industry News
    • Industry Links
    • Knowledge Center
    • Glossary
  • Join Us|
    • Career Opportunities
  • Contact

Process

  • Manufacturing and Quality
  • Our Innovation
  • Certifications
  • Home
  • Product
  • Manufacturing and Quality

MANUFACTURING AND QUALITY

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

    Medisafe Technologies:

    Commitment to Excellence and Compliance


    Excellence in the Global Glove Industry

    PT. Medisafe Technologies is committed to setting new benchmarks of excellence in the global glove industry. We consistently uphold world-class standards across several critical areas, including Environmental Management Systems, Occupational Health and Safety, Business and Social Compliance, as well as Product Safety Compliance.


    Internationally Recognized Certifications

    Medisafe Technologies has achieved numerous internationally recognized quality certifications. Notably, we were the first Indonesian glove manufacturer to be awarded with ISO 13485 certifications, marking a significant achievement within the industry.


    Continuous Improvement in Quality Standards

    In 2005, Medisafe Technologies obtained the ISO 13485 Certification. This certification serves as a global quality standard for the medical device sector, addressing specific quality and safety requirements for medical devices in addition to the basic ISO 9001.

    To enhance further, Medisafe continues to meet the requirements of the industry and received the MDSAP certification in 2023 and MDR certification in 2024.


    Environmental and Occupational Health Achievements

    In February 2015, reaffirming our commitment to environmental protection and employee safety, Medisafe Technologies secured leading certifications: ISO 14001:2015 for Environmental Management Systems, OHSAS 18001:2007 for Occupational Health and Safety Management, and HACCP for the control of chemical and biological hazards. At that time, only a select few in the industry held these prestigious distinctions.

    In 2020, building upon continued compliance with OHSAS 18001, we were the first company in Indonesia's glove medical device industry to transition smoothly to ISO 45001, underscoring its leadership in occupational health and safety.


    Energy Management System

    We are committed to achieving excellence in Energy Management System (EnMS) by fostering a culture of continual improvement, innovation, and collaboration across all departments and functions.

    We strive to enhance our energy performance through efficient utilization of resources, adoption of appropriate technologies, and integration of energy management practices into its operational and strategic decision-making processes. Through active involvement of employees, suppliers, and relevant stakeholders, Medisafe promotes shared responsibility, awareness, and accountability for sustainable energy use. Our organization is further committed to fulfilling applicable legal and other requirements, establishing and reviewing energy objectives and targets, and continually improving the effectiveness of the EnMS to support environmental sustainability and long-term business success. These initiatives and efforts were highly recognised by the Ministry of Industry and Environment thru various awards and certifications. All these dedicated efforts culminated in a significant achievement in September 2025, where we successfully obtained ISO 50001 certification, a testament to the team's commitment and hard work in meeting the premier International standard in EnMS. This milestone marked the realization of our objectives and highlighted the effectiveness of our continuous improvement.


    Business Social Compliance and Ethical Trade

    Building on its earlier achievement of the industry's highest ratings in the Business Social Compliance Initiative (amfori BSCI), Medisafe became the first in the industry to earn WRAP GOLD certification on its initial attempt in 2019.

    In 2022, PT. Medisafe Technologies set another industry milestone by being the first to achieve the WRAP Platinum Certification. We continue to maintain this status during the bi-annual recertification in 2024, while continuing to maintain SEDEX membership and our group (YTY) being one of the seven founding members of Responsible Glove Alliance (RGA), reflecting its unwavering commitment to ethical business practices and social responsibility.


    HCCP
    ISO 9001
    ISO 14001
    ISO 50001
    ISO 13485
    WRAP

  • 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

    1 Select gloves

  Our Innovation
  • Legal & Privacy
  • Sitemap
Copyright © 2014 Medisafe Technologies | All Rights Reserved.