Patient Personal Hygiene Kit

What Is This Device?

This device contains items given to an individual during their hospital stay.

How Is NSB Classified?

Patient Personal Hygiene Kit is FDA product code NSB, Class 1, 21 CFR 872.6855.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Do the Recalls Say?

The FDA has recorded 16 recalls under this product code since 2018. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (6), Process control (2) and Device Design (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.