DeviceClearance

Product code KGO— General, Plastic Surgery

SURGEON'S GLOVES

Classification name
Surgeon'S Gloves
Device class
Class 1
Regulation
21 CFR 878.4460
Advisory panel
General, Plastic Surgery
Total cleared
560
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code KGO under 21 CFR 878.4460, via openFDA

Market context for product code KGO

FDA has cleared 560 devices under product code KGO between 1976 and 2026, filed by 265 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code KGO

Recent clearances under product code KGO

1–100 of 560

Data sourced from openFDA. This site is unofficial and independent of the FDA.