Surgeon’S Gloves

What Is This Device?

A surgeon’s glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

How Is KGO Classified?

Surgeon’S Gloves is FDA product code KGO, Class 1, 21 CFR 878.4460.

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 21 clearances under this code; the FDA took a median of 153 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 44 recalls under this product code since 2002. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process control (10), Labeling mix-ups (8) and Device Design (8). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.