Certifications

Hartalega is a name whereby many associate with Premium Quality. As a commitment to this reputation, we have set up the following world-class quality systems.

ISO 9001:2000

Download :
ISO 9001:2000 (270 KB)

ISO 13485:2003

Download :
ISO 13485:2003 (587 KB)

EN ISO 13485:2003

Download :
EN ISO 13485:2003 (200 KB)

EC-Certificate

Download :
EC-Certificate (295 KB)

CE Marking

Download :
CE Marking (442 KB)

Standard Malaysian Glove - Powder Free

Download :
Standard Malaysian Glove (89 KB)

Standard Malaysian Glove - Powdered

Download :
Standard Malaysian Glove (91 KB)

Medical Device Licence - Health Canada

Download :
Health Canada (940 KB)
Health Canada (874 KB)

Canadian General Standards Board Certificate

Download :
Canadian General Standards Board Certificate (457 KB)

U.S. Food and Drug Administration 510(k)
Registration of U.S. Food and Drug Administration