Attributes . ASTM D6319, Category III, CE 0493, EN 16523-1, EN 455 1-4, EN ISO 21420:2020, EN ISO 374-1:2016, A1:2018, EN ISO 374-5:2016, FDA21 CFR 177-2600-US Food Contact Approved, Food Contact, IFU, ISO 13485, ISO 18889:2019, ISO 9001, Medical Device Regulation (EU) 2017/745 Class I, US QSR/FDA 510(k) Medical Examination Grade . Names