DeviceClearance

Product code LZC— General Hospital

ABSOGEL CHEMOTHERAPHY GLOVES

Classification name
Medical Glove, Specialty
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Total cleared
79
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code LZC under 21 CFR 880.6250, via openFDA

Market context for product code LZC

FDA has cleared 79 devices under product code LZC between 1989 and 2026, filed by 59 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 LZC

Recent clearances under product code LZC

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