The 1998 launching of the Standard Malaysian Glove (SMG) scheme for pre-powdered and powder-free natural rubber latex (NRL) examination gloves by the Hon. Minister of Primary Industries heralded the beginning of a new era for the Malaysian NRL glove industry. Malaysian officials believe this will demonstrate to the world its earnest endeavor to address the latex protein challenge by being the first to incorporate, among other things, a maximum limit of total extractable protein for NRL gloves in its SMG scheme. The technical parameters specified in the scheme were derived at after consultation with regulatory agencies such as the U.S. Food and Drug Administration (FDA), standards organizations such as the American Society for Testing and Materials (ASTM), consumers, glove manufacturers,
testing laboratories and government authorities.
The SMG Technical Committee has made adjustments to the SMG specifications after an in-depth study of customers' demands. The revised specifications for the extractable protein content and residual powder content of pre-powdered gloves are now in line with those stipulated in ASTM's standard specifications for Rubber Examination Gloves D 3578-99. In respect of the specifications for powder-free gloves, the limits for total extractable protein content and residual powder content for SMG are more stringent than those contained in ASTM D 3578-99.
Under this Scheme, certified Malaysian glove manufacturers will be monitored at regular intervals so that the gloves they produce are with-in or better than SMG specifications. As in any risk management practice, the principle of As Low As Reasonably Achievable (ALARA) or As Low As Reasonably Possible (ALARP) has been used to determine the limits on protein and residual powder content.
Through the SMG scheme, the twin forces of self-regulation of the NRL glove industry and increasing stringent market demand for SMG would ultimately bring to bear on the overall improvement of NRL gloves. The scheme should prove to be a win-win formula for all in the healthcare world.
Standard Malaysian Glove (SMG). A complete copy of this publication, ISBN 983-2088-03-8, can be obtained from the Malaysian Rubber Board, Rubber Research Institute of Malaysia, P O Box 10150, 50908 Kuala Lumpur, Malaysia.
