Primus Gloves-The Quality

The Quality

We believe in and strive for the involvement of every member of the company in quality improvement procedures and shall maintain the effectiveness of the processes.

We shall endeavor to develop the necessary skills and shall build an attitude essential for a proactive work culture.

We shall operate under dynamic quality system complying with the requirements of EN ISO 13485:2016 for all operations and additionally that of US FDA QSR for medical devices operations.

Quality Certifications

		Patent Certificate for Polymer Coated Powder FREE Gloves
		ISO 13485:2016/NS-EN ISO 13485:2016 by DNV Product Assurance AS, Norway
		Cerificate - DNV Product Assurance AS, Norway Appendix issued to EC Certificate issued for manufacturer Appendix issued to EC Certificate issued for manufacturer
		US FDA 510(K) number for various products. Facility successfully inspected by USFDA in Feb 2005 and Aug 2010

Test Reports

Our gloves are tested for the various glove properties in internationally acclaimed laboratories across the world.

	Bio-compatibility test (Primary skin irritation & dermal sensitization)
	Toxicity test
	Bioburden test
	Pyrogen test
	Endotoxin test
	Residual chemicals test
	Revised ethylene oxide test

With PRIMUS, it is always more than just SAFETY.

These certification and endorsement are testimony to our continuous efforts in consistently producing high quality gloves.

Primus Gloves Private Limited
Plot No. 14 A, Cochin Special Economic Zone, Cochin - 682 037, India. Tel : 91 484 2413063, 2413076. Fax : 91 484 2413089.
E-mail: marketing@primusgloves.com, primusgloves@gmail.com

EU Representative
Amstermed BV Saturnusstraat 46-62, Unit 032, 2132 HB Hoofddrop, The Netherlands. Phone: +31 23 5656337
E-mail: info@amstermed.nl,Website: www.amstermed.nl