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Rubber Enema Bulbs from Japan

Flexible squeeze bulbs made of vulcanized rubber used with tubing for pharmaceutical enemas and colon cleansing. Classified in HTS 4014.90.50.00 as pharmaceutical articles of soft vulcanized rubber.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• Obtain FDA Class I device listing; ensure biocompatibility testing per ISO 10993

• Provide sterilization method validation; common issue is residual latex proteins

• Declare as medical device on entry to avoid reclassification as general rubber goods