DeviceClearance

Product code LYZ— General Hospital

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

Classification name
Vinyl Patient Examination Glove
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Total cleared
799
First cleared
Most recent

FDA classification definition

“A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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 LYZ under 21 CFR 880.6250, via openFDA

Market context for product code LYZ

FDA has cleared 799 devices under product code LYZ between 1989 and 2026, filed by 416 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 LYZ

Recent clearances under product code LYZ

1–100 of 799

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