Abstract
Summary Due to the dramatic increase of type I allergies to natural rubber latex gloves the working group 3 of CEN TC 205 decided to include the biological evaluation into the standard EN 455, medical gloves for single use. A study supported by the European Community and a harmonisation between ASTM, ISO and CEN finally led to a standard procedure for the determination of extractable proteins in latex gloves. This method was shown to be the most useful method that revealed (except of some outliers) allergological relevant protein values. The most important steps of the method are: 1. Double glove extraction (or equivalent), 2. TES buffer pH 7.4 (or equivalent), 3. 2 h , 25 C°, moderate agitation, 4. Modified Lowry, 5. Values shall be given in μg/g glove. Although not useful as a standard procedure, the amino acid analysis (by HPLC) for total protein determination is recommended as reference method, because it revealed the best correlation to the allergological response. The immunological methods are not recommended at present, because standardized antibodies and standard allergens are not available.
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