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Manufacturing and Quality

Manufacturing

Producing Top Quality Disposable Gloves, Every Day

Located in Medan, Indonesia, our five ISO 13485, 14004 and 18001 certified manufacturing plants produce over 2.3 billion disposable medical, surgical and industrial gloves annually on fully automated high speed lines. Our facilities operate under Good Manufacturing Practices (GMP) and conform to the requirements of the US FDA Quality System Regulation (QSR) and the Europe’s Medical Device Directives 93/42/EEC.

Throughout our production process there are built in redundancies to ensure that every glove is manufactured to our exacting standards and yours. Samplings are randomly taken from every production line regularly and checked for physical dimensions and physical properties. If it isn’t right, you won’t see it.

Our proprietary formulations and manufacturing processes produce the strongest and softest low modulus gloves in the industry today. We are the pioneer in Chloroprene – a polymer boasting a unique combination of strength and durability yet so comfortable for extended wear. A glove so unique, Medisafe Technologies was awarded a US patent for Chloroprene exam gloves – the only Southeast Asian manufacturer to hold this distinction.

We believe in controlled growth and expansion; building capacity for the future to meet our customer’s needs and not on size or volume claims. This philosophy has guided us since our inception and allowed us to grow responsibly, increasing our capacity four-fold in the last ten years.

We take equal care with packaging, layering each glove after production to make sure our gloves look as good as they wear. Special packaging requirements – don’t worry. We utilize a network of leading printers and packaging material suppliers that understand your business and can address your specific needs.

Environmental, Health and Safety

Safety for the Environment, our Community and our Employees

We understand how fragile our environment is and its protection is deeply rooted in our culture.  Medisafe has committed itself to becoming a leader in Environmental, Health and Safety (EHS) initiatives to safeguard our employees, visitors, plants and community.  To that end, we have achieved internationally recognized certifications for ISO 14001 Environmental Management System and OHSAS (ISO) 18001 Occupational Health and Safety Management certifications, achievements few in our industry hold today.

We continuously look for ways to reduce our carbon footprint through proactive green environmental practices. 

  • Over 98% of our energy use is fueled by renewable biomass sources greatly reducing dependency on fossil fuels and natural gas
  • Waste heat from our boilers runs our HVAC system and chillers and an on-site water treatment plant ensures our effluents are safe for discharge without harm to the environment or our community 

Today our efforts yield gloves produced with very low carbon emissions – our goal for tomorrow, even less.  

Our employee’s safety is paramount and to ensure we meet this obligation we employ a comprehensive safety program to proactively identify hazards and risk involved throughout our plants and provide regular training and testing of the safety system to maintain skills and readiness.   

Quality

Quality is Top of Mind. Every Glove, Every Day

Quality is foremost in what we do every day.  We are proud to be the first Indonesian glove manufacturer to achieve EN 46002 and ISO 13485 certifications, internationally recognized quality management systems. We employ the most stringent quality criteria to every glove produced and perform a 3-tier quality check and pre-dispatch inspection to ensure that only the highest quality gloves arrive at your door.

Our Quality System

We understand the critical role gloves play in protecting people and products from the risks they see and the ones they don’t.  From the physician to the pharmaceutical manufacturer we provide only the highest quality disposable gloves that meet our exacting standards and yours, every glove, every day.

Our quality system begins before the first glove is produced.  Every raw material supplier is subjected to our certification process to assure what goes into your gloves is of the highest quality and what comes out is the same.  All incoming raw materials are inspected and monitored for compliance to specifications, consistency and performance.

Medisafe gloves are tested in our state-of-the art laboratory facilities using ISO, ASTM and EN international standards and sampling requirements 24/7.  Product quality is monitored at each stage of production by our laboratory technicians to ensure that product always conforms to international standards and our even stricter internal ones.

Our medical gloves meet or exceed US Food and Drug Administration (FDA) and European Union Medical Device Directives 93/42/EEC requirements for quality and performance.  In addition, we utilize ISO-accredited external testing laboratories to validate our internal results and compliance with rigorous ASTM and EN standards for chemical and chemotherapeutic permeation, endotoxicity, cytotoxicity and viral penetration among others.

Every production lot is inspected for:
1. Major defects: Pinholes, tensile strength, elongation, aging properties
2. Minor defects: Discoloration, tackiness, thin spots, beading quality, stains and embedded particles
3. Physical properties:  Cuff length, palm width and thickness

All critical process parameters are checked and certified on a daily basis and we adhere to well-established non-conformance and corrective action procedures to monitor and control the quality, day in and day out. All non-conforming products are subjected to 100% testing to ensure we deliver the quality you have entrusted to us. 

At Medisafe, we take care of you.