Latex Patient Examination Glove

What Is This Device?

A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

What Is FDA Product Code LYY?

Latex Patient Examination Glove is FDA product code LYY, 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 56 clearances under this code; the FDA took a median of 110 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 6 recalls under this product code since 2002. None was by a company in China. The root cause the FDA records most often is Release of Material/Component prior to receiving test results (1).

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