Tampon, Menstrual, Unscented

What Is It?

An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

How Is HEB Classified?

Tampon, Menstrual, Unscented is FDA product code HEB, Class 2, 21 CFR 884.5470.

How Does It Reach the US Market?

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 97 days from receipt to decision on them.

4 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 36 recalls under this product code since 2010. None was by a company in China. The root causes the FDA records most often are No Marketing Application (29), Storage (1) and Material/Component Contamination (1).

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