Section ten : quality standard Malaysian gloves
Quality Standard Malaysian Gloves (SMG) that meet today’s healthcare challenges - Dato’ Dr.Ong Eng Long, FASc, Deputy Chief Executive Officer, Malaysian Rubber Export Council (MREPC)
Dr. Ong gave a detailed and informative presentation of the quality Standard Malaysian Glove (SMG) scheme for quality latex examination gloves (powdered and powder-free). These limit protein and powder levels in quality latex examination gloves and also comply with the technical specifications of FDA and ASTM standards. These developments have followed extensive research into latex proteinallergy and into consumer requirements as well as the views of regulatory agencies, manufacturers and testing laboratories.
The Scheme provides consistent minimum quality standards for gloves and requires manufacturers to have in place a quality management system that meets ISO 9002 or its equivalent. Performance and compliance is subject to independent surveillance, checking and testing to ensure consistent compliance at all times. The objective of the SMG scheme is to provide a quality assurance and product guarantee by focussing on the '4 Ps' - Protein level, Powder content, Pinholes and Physical properties. 23 glove manufacturers in Malaysia are currently certified to be SMG producers (50% of Malaysia’s total glove production capacity) and all glove manufacturers are being urged to adopt the SMG programme.
Under the scheme, there are two separate categories of examination gloves: powdered and powder-free. Each has a specified upper limit of residual extractable proteins based on scientific studies involving collaboration with experts active in the field of allergy research. Specifications are also set for tensile properties and watertightness, reducing risks of pinhole formation and improving glove performance. Compliance with the Scheme is subject to surveillance by the Rubber Research Institute of the Malaysian Rubber Board, and the Scheme is also subject to revision and upgrading in line with consumer requirements and FDA standards.
Dr. Ong began by reviewing the positive attributes of NRL gloves in terms of their barrier performance, strength, elasticity, biodegrability and other positive physical properties. Latex sensitive individuals should practice latex avoidance. He warned that vinyl gloves (the main synthetic alternative in use) have been shown to be 5 - 13 times more likely to leak than NR Latex gloves during use, and that synthetic products are made from monomers that are may be either toxic or carcinogenic and are not biodegradable. Disposal by burning may have harmful environmental effects.
He then looked at the adverse reactions associated with these gloves, the key issues being extractable protein and the use of powder that had been reported to carry the proteins. He went on to outline the actions taken in Malaysia to address the problem, through studies of proteins in latex and latex products and by removing or reducing proteins in latex and end products. He described the technical processes involved in producing low protein latex, and summarised the technologies for product improvement and treatments. He also discussed the reported issues relating to cornstarch powder used in powdered gloves, which acts as an aeroallergen, absorbing protein from the glove. Once airborne, this can lead to risks of hazardous exposure and sensitisation or allergic reaction if inhaled.
Finally, Dr. Ong described the methods used to reduce risks of latex sensitisation, including minimising extractable protein levels and powder content, using newly developed technologies and treatments to achieve these reductions. He also cited the possible future substitution of oatstarch for cornstarch, as it has been reported not to bind proteins in the same way, but stressed that this was at a very early stage of development. He believed that lower protein levels were the key to minimising sensitisation whilst at the same time ensuring that barrier protection against virus transmission is not compromised.