วัสดุอุปกรณ์การแพทย์ เวชภัณฑ์
เอกสารมาตรฐาน
สหรัฐอเมริกา
ASTM
D6319-19
Standard Specification for Nitrile Examination Gloves for Medical Application
2019
4
Vol.09.02
This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile or nonsterile or bulk nonsterile. An approved lubricant for absorbable dusting powder may be applied to the gloves. Other lubricants may also be used, provided, that their safety and efficacy have been previously established. Both the inside and outside surface of the glove should be free of talc. All products should meet the required degree of sterility, freedom from holes, physical requirements before and after ageing, amount of powder on the glove, tensile strength and ultimate elongation.