DeviceClearance

Product code LYY— General Hospital

PATIENT EXAMINATION GLOVES (LATEX)

Classification name
Latex Patient Examination Glove
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Total cleared
1,954
First cleared
Most recent

FDA classification definition

“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.”

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

Market context for product code LYY

FDA has cleared 1,954 devices under product code LYY between 1988 and 2025, filed by 1,102 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 LYY

Recent clearances under product code LYY

1–100 of 1,954

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