KGO

Surgeon'S Gloves

Product code

KGO

Device name

Surgeon'S Gloves

Device class

Class 1

21 CFR

21 CFR 878.4460

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

9

Summaries archived here

6 (direct download)

510(k) clearances (all years, FDA)

560 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (9)

Last three years. Most recent: 2026-07-28.

6 summaries are archived here for direct download.