Lubricant, Personal

What Is This Device?

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body’s natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

What Is FDA Product Code NUC?

Lubricant, Personal is FDA product code NUC, Class 2, 21 CFR 884.5300.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 11 clearances under this code; the FDA took a median of 185 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are No Marketing Application (4), PMA (1) and Storage (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.