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ASTM D6319, Category III, EN 420:2003 + A1:2009, EN 455 1-4, EN 455 1-4, EN ISO 374-1:2016, EN ISO 374-5:2016, FDA21 CFR 177-2600, FDA 510K, ISO 10993-10:2002, ISO 9001, ISO 13485 300 gloves per dispenser 10 dispensers per case 3000 gloves per case