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As the world's leader in medical gloves, Malaysia is committed to supplying gloves of an internationally high standard for quality, safety and reliability. We take pride in introducing the Standard Malaysian Glove (SMG) program, a joint effort by the Malaysian Rubber Board's Rubber Research Institute of Malaysia (RRIM) and the Malaysian Rubber Glove Manufacturers' Association (MARGMA)

The SMG program was developed in consultation with regulatory and standard setting bodies such as the U.S. Food and Drug Administration (FDA) and other relevant authorities.

The SMG program establishes standards not only for barrier performance, the single most important function of medical gloves, but also for protein and powder contents, the former believed to cause allergic reactions in individuals sensitive to latex proteins and the latter serving as a carrier for such proteins.

The program applies to medical examination gloves, both powdered and powder-free. They are identified by a green logo for powder-free gloves and an orange logo for the lightly powdered variety. However, SMG may also be identified by the presence of the SMG logo, printed in the dominant colour of the dispenser box, with the type of gloves, powdered or powder-free, clearly indicated on the dispenser box.

SMGs are consistent in quality, ensuring barrier protection and minimizing protein sensitization.

All SMG manufacturers must have a quality management system in accordance with ISO 9001-2000 or its equivalent.

SMG certification is carried out by the Rubber Research Institute of Malaysia of the Malaysian Rubber Board, which is accredited to ISO/IEC Guide 65 as a Product Certification Body.

By setting clearly defined specifications for barrier function, strength, elasticity, and protein and powder content that are in line with FDA and ASTM technical specifications, the SMG program provides users with gloves that are consistently superior in barrier protection and with reduced risk of protein sensitization.

Ensuring barrier protection

All SMG labeled gloves must meet the prescribed standard for the water leak test, the internationally-recognized testing procedure for barrier performance. Gloves are sampled and inspected in accordance with ISO 2859-1. Under the SMG program, the Acceptable Quality Level (AQL) of 1.5 at inspection level of G1 compares favorably with ASTM (AQL of 2.5) and FDA requirements for examination gloves.

High strength and elasticity are important to minimize the possibility that gloves will rupture or tear under in use stress conditions. These characteristics are measured on the basis of tensile strength and elongation-at-break. The requirements under the SMG program are shown below:

Minimizing protein sensitization

SMG is designed to ensure that natural rubber latex gloves can consistently meet low protein and powder content as stipulated by the program. In the case of SMG powdered gloves, protein and powder contents are kept at very low levels of 200 microgram/dm² and 150 milligrams/glove or less respectively.The protein and powder contents of SMG powder-free gloves are even much lower at 50 microgram/dm² and 2 milligrams/glove or less respectively.

The table shows the upper limit set for protein and powder under the SMG program.

• Important Facts on Latex and Latex Gloves
• The Facts About SMG Gloves :
  • SMG Latex Glove Provide Superior Barrier Protection, Superior All-around Performance, Low Allergy Risk
  • Hospital Studies I : Improved Natural Rubber Latex Gloves Reduce Allergy Risk
  • Hospital Studies II : More Hospital Studies Endorse Low Protein, Powder-Free Natural Rubber Latex Gloves
  • Studies Show Improved Latex Gloves Greatly Reduce Protein Allergy Risk
• ECRI Recommend Use of SMG Gloves

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