PFOS Medical Device Lubricant from China

Sterile lubricant preparation containing perfluorooctane sulfonyl fluoride for medical device manufacturing and assembly. Classified in HTS 3824.87.00.00 under subheading note 3 specifications for PFOS substances.

Duty Rate — China → United States

38.7%

Rate breakdown

9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter
9903.88.0325%Except as provided in headings 9903.88.13, 9903.88.18, 9903.88.33, 9903.88.34, 9903.88.35, 9903.88.36, 9903.88.37, 9903.88.38, 9903.88.40, 9903.88.41, 9903.88.43, 9903.88.45, 9903.88.46, 9903.88.48, 9903.88.56, 9903.88.64, 9903.88.66, 9903.88.67, 9903.88.68, or 9903.88.69, articles the product of China, as provided for in U.S. note 20(e) to this subchapter and as provided for in the subheadings enumerated in U.S. note 20(f)

Import Tips

Provide FDA device master file or drug master file references

Include biocompatibility test results (ISO 10993) for medical lubricants

Maintain USP <88> Class VI certification records