achievementsHead of our group Mr. A. Kurian accepting CAPEXIL's Special Export Award from the Honourable Minister for Finance Mr. P. Chidambaram
A total growth rate of more than 5000% has been achieved in our operations. Our state of the art factories integrates all modern machinery, thus allowing us to become a world leader in manufacture of latex surgical gloves.
Certificate of Merit for Exports for four consecutive years was awarded to us by CAPEXIL. Our exemplary export performance has been recognized by the Government of India and we have been awarded The Special Export Award for two consecutive years by CAPEXIL . We have also been given Star Export House Status by the Indian Government. This speaks for the company's commitment to produce a Quality product. Stringent Quality Standards have earned the prestigious ISO 9001:2000 and CE Certification along with ISO-13485:2003 (certification of quality management systems, specifically for medical devices). We are also registered with U.S.FDA (510K) and have the India Bureau of Standards' ISI Certification.
The products are accepted the world over and a few of the countries it is registered in are: U.S.A. AUSTRALIA, EUROPEAN UNION, HUNGARY, POLAND, ROMANIA, LITHUANIA, COSTA RICA, COLOMBIA, ECUADOR, BRAZIL, CHILE and MEXICO. We have been directly audited by the U.S. F.D.A. & our systems & practices have been found to be in compliance.
GMP FOR SURGICAL GLOVES
A Glove is a protective device. A Surgical Glove is much more than a protective device - it is a MEDICAL DEVICE, used in invasive surgery in a sterile area. A good glove therefore should not have any bio irritants present on the glove, which can cause health hazards to user and patient.
Natural Rubber Latex is the best Polymer for Surgical Glove as it provides optimum barrier properties, elasticity, comfort, fit and cost, and it has been used for Centuries.
However, recently Latex Gloves have come to be associated with Latex Allergies. What causes the allergy? Is it Natural Rubber Latex or the Manufacturing process adopted within the last two decades - first to meet increased demand and subsequently to reduce cost to sell gloves at a cheaper price due to competition, since supply currently exceeds demand?
It is the unscrupulous manufacturing practices that contribute to latex allergies from gloves. The critical parameters that need special controls, apart from the physical properties and dimension for Surgical Gloves are:
- BARRIER PROPERTIES
- BIO BURDEN LEVEL ON GLOVES
- BACTERIAL ENDOTOXIN LEVELS
- MOISTURE CONTENT ON GLOVES
- RUBBER CHEMICAL RESIDUE
- LEACHING AND QUALITY OF WATER USED
- EXTRACTABLE LATEX PROTEIN
- QUALITY AND QUANTITY OF DONNING POWDER
- PACKING MATERIAL AND PACKING SYSTEM
- STERILIZATION PROCESS AND STERILITY ASSURANCE