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3904.61.00/High-Purity PTFE Granules/Japan

High-Purity PTFE Granules from Japan

Pharmaceutical-grade polytetrafluoroethylene granules with ultra-high purity (>99.9% PTFE), used in medical device molding. Falls under HTS 3904.61.00 per strict 95% monomer content rule for named polymers.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%
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Import Tips

• Include USP Class VI or ISO 10993 biocompatibility certificates for CBP review

• Test for extractables to confirm purity and prevent reclass to mixtures