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Jun 15, 2020·The FDA’s process for importing medical gloves to the USA. Medical gloves are class I reserved devices and are subject to general controls (section 513 (a) (1) (A) and 510 (l) (1) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c (a) (1) (A)), which include: Establishment Registration. Device Listing (CFR 21 807) – this ...

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Jun 15, 2020·The FDA’s process for importing medical gloves to the USA. Medical gloves are class I reserved devices and are subject to general controls (section 513 (a) (1) (A) and 510 (l) (1) of the Federal Food, Drug, and Cosmetic Act (Act); 21 U.S.C. 360c (a) (1) (A)), which include: Establishment Registration. Device Listing (CFR 21 807) – this ...

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May 04, 2015·Since 1984, Shen Wei USA, Inc. has been a leading manufacturer of premium latex, nitrile, and vinyl medical and industrial disposable gloves. Our passion to think outside the box has brought new ideas and products that have transformed human health. Our dedication to quality, innovation, and customer care are powered by a team inspired to make ...

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