Medical Glove, Specialty

What Is It?

A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

How Is LZC Classified?

Medical Glove, Specialty is FDA product code LZC, Class 1, 21 CFR 880.6250.

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 9 clearances under this code; the FDA took a median of 85 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 8 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Release of Material/Component prior to receiving test results (4), Component design/selection (1) and Labeling mix-ups (1).

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