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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.