01 September 2016
On the 1st of September 2016, KOSSAN Rubber Industries Berhad (KOSSAN®) officially launched its LOW DERMA® Technology at an event held at the Le Meridien Hotel Kuala Lumpur. Its LOW DERMA® Technology has made KOSSAN® the first Malaysian glove manufacturer in the world to be granted the ‘Low Dermatitis Potential’ claim in gloves by the United States Food & Drug Administration (FDA). This milestone achievement places KOSSAN at the forefront of a world-wide solution for hypersensitivities predominant in glove wearers.
This patented technology offers all-round protection from Type I and Type IV hypersensitivity. LOW DERMA® Technology makes its debut in KOSSAN’s house brand, CHEMAX® 7th Sense® gloves. CHEMAX® 7th Sense® gloves is a revolutionary, new-generation nitrile glove featuring soft-touch, hand-felt comfort and superior barrier protection. Formulated as pure as possible, without chemical accelerators, CHEMAX® 7th Sense® gloves is the desired solution to global glove protection needs.
In between 1985 to 1988, when the Human Immunodeficiency Virus (HIV) was first discovered in the United States of America, and found to be transmitted by bodily fluids, the Centers of Disease Control enforced the Universal Precaution guideline. This refers to the practice of avoiding contact with patients' bodily fluids, by means of the wearing of nonporous articles such as medical gloves, goggles, and face shields. This move was so successful in preventing the transmission of HIV that Universal Precaution was adopted in most countries around the world. Gloving up was soon standard practice in all medical examination rooms and hospitals.
However, while Universal Precaution helped curtail the spread of viruses and cross-contamination, the increased use of examination and surgical gloves resulted in an increase in complaints of skin conditions among those in the medical fraternity. Soon, professionals in other industries which also depended on the use of gloves to assure hygiene and safety were also reporting adverse skin conditions.
Key among these skin complaints were incidences of Type I latex hypersensitivity, an immune response which can develop following exposure of glove users to natural rubber latex. Redness, itchiness, blistering, scabbing and weeping sores or cracked hands were some of the signs of the hypersensitivity. So too was reduced productivity and a decrease in the quality of life of the sufferers. Painful, unattractive hands gave rise to the inability to function normally in day-to-day settings, as hypersensitised hands made it difficult to bathe, perform cleaning chores and function normally.
Because Universal Precaution continued to apply in the medical field, dermatologists and allergists advised people affected by Type I hypersensitivity to switch from the use of natural rubber latex gloves to nitrile or synthetic gloves. However, while nitrile gloves did not contain the latex proteins which affected those with Type I hypersensitivity, the gloves were manufactured with the use of chemical accelerators which affected people with Type IV hypersensitivity.
Dr. Saadiah Sulaiman, a Malaysian dermatology expert who worked closely with KOSSAN on the testing of the LOW DERMA® Technology says, “Accelerator-free gloves are manufactured using a breakthrough cross-linking technology that does not use chemical accelerators. The result is a thin, soft and stretchy glove that is actually stronger than traditionally manufactured nitrile glove material. Low-Dermatitis Potential is a United States FDA-approved claim reserved for gloves that have been tested to contain low levels of chemical accelerator residue that will not induce skin irritation and will not cause any potential sensitisation reaction.”
As part of its rigorous product testing, the new gloves were subjected to a Modified Human Draize Test with a sample size of 200 non-sensitised adults. Out of the 200 subjects, 152 were Caucasian (76%), 30 were Afro Caribbean (15%) and 18 were Asiatic (9%) – between the age of 18-48 years old – 102 were male (51%) and 98 were female (49%) The test showed negative results which means no clinical evidence on the presence of residual chemical additive at the level that may induce Type IV allergy in the unsensitised general users. This translates to more than 95% confidence that the chemical sensitisation potential is low.
Another test on 27 users with occupational contact dermatitis (Type IV hypersensitivity) conducted in Japan clinically proved that the use of CHEMAX® 7th Sense® gloves resulted in more than 85 percent of the patients showing either improvement in skin condition or no worsening of the sensitised skin after using the gloves for four weeks at work.
On further LEAP Testing Services on American Society for Testing & Materials D7558 (ASTM D7558), no accelerators were detectable in the gloves with LOW DERMA® Technology. The LEAP Testing Service is an independent testing laboratory at the Donald Guthrie Foundation for Education and Research in Philadelphia, America.
Rounds of rigorous, independent international testing have proven the validity of KOSSAN’s LOW DERMA® Technology. Japanese company Midori Anzen, with its strong track record in patents worked hand in hand with KOSSAN in the research technicalities related to the patent filing process. The LOW DERMA® logo has also been trademarked and will act as an identifying mark, symbolising superior product reliability and safety.
With innovation always being a driving force at KOSSAN, the company continues to look at future and current day solutions for the industry in order to anticipate needs as opposed to merely responding to them. KOSSAN’s commitment to innovation is seen in its established Research and Development department where laboratory research findings are always put to good use in commercial applications.
KOSSAN Founder and Chief Executive Officer Dato’ Lim Kuang Sia in his speech affirmed that KOSSAN espoused a strong culture of “technology driving excellence.” He said, “LOW DERMA® Technology is our attempt to produce a ‘greener’ medical glove, with a reduced use of chemicals. We strongly believe our LOW DERMA® Technology can be applied to the production of gloves used for non-medical purposes as well.”