Walsh Donna L, Schwerin Matthew R, Kisielewski Richard W, Kotz Richard M, Chaput Maria P, Varney George W, To Theresa M
Office of Science and Technology (HFZ-150), Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, Maryland 20852, USA.
J Biomed Mater Res B Appl Biomater. 2004 Jan 15;68(1):81-7. doi: 10.1002/jbm.b.10055.
Due to the increasing demand for nonlatex medical gloves in the health-care community, there is a need to assess the durability of alternative glove materials. This study examines durability characteristics of various glove materials by abrasion resistance testing. Natural rubber latex (latex), polyvinyl chloride (vinyl), acrylonitrile butadiene (nitrile), polychloroprene (neoprene), and a styrene-ethylene/butylene-styrene block copolymer (SEBS) were tested. All test specimens, with the exception of the vinyl, were obtained from surgical gloves. Unaged out-of-the-box specimens as well as those subjected to various degrees of artificial aging were included in the study. After the abrasion sequence, the barrier integrity of the material was assessed through the use of a static leak test. Other traditional tests performed on these materials were viral penetration to validate the abrasion data and tear testing for comparative purposes. The results indicate that specific glove-material performance is dependent upon the particular test under consideration. Most notably, abrasion, even in controlled nonsevere conditions, may compromise to varying degrees the barrier integrity of latex, vinyl, SEBS, nitrile, and neoprene glove materials. However, as evidenced by the results of testing three brands of neoprene gloves, the abrasion resistance of any one glove material may be significantly affected by variations in production processes.
由于医疗保健领域对非乳胶医用手套的需求不断增加,因此有必要评估替代手套材料的耐用性。本研究通过耐磨性测试来检验各种手套材料的耐用性特征。对天然橡胶乳胶(乳胶)、聚氯乙烯(乙烯基)、丙烯腈丁二烯(丁腈)、聚氯丁二烯(氯丁橡胶)和苯乙烯 - 乙烯/丁烯 - 苯乙烯嵌段共聚物(SEBS)进行了测试。除乙烯基手套外,所有测试样本均取自手术手套。研究中纳入了未开封的未老化样本以及经过不同程度人工老化的样本。在进行磨损测试后,通过静态泄漏测试评估材料的屏障完整性。对这些材料进行的其他传统测试包括病毒穿透测试以验证磨损数据,以及进行撕裂测试以作比较。结果表明,特定手套材料的性能取决于所考虑的具体测试。最值得注意的是,即使在受控的非恶劣条件下,磨损也可能在不同程度上损害乳胶、乙烯基、SEBS、丁腈和氯丁橡胶手套材料的屏障完整性。然而,通过对三个品牌氯丁橡胶手套的测试结果证明,任何一种手套材料的耐磨性可能会受到生产工艺变化的显著影响。