Japan Regulations - Resistance of Medical Gloves to Permeation

C

chingy

Hello everyone! I work for a manufacturer of medical device, exam gloves to be used for chemotherapy drugs. FDA follows [FONT=&quot]ASTM D6978-05 ?Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs? to test for chemo use their minimum glove thickness accepted is .10mm.

I am wondering if JAPAN has its own testing standard for chemo claim and if they have a similar minimum for glove thickness like FDA. I had been researching and could not find anything.. any help will be highly appreciated!!

Thank you! :tg:
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