DeviceClearance

Product code LZA— General Hospital

Nitrile Examination Gloves

Classification name
Polymer Patient Examination Glove
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Total cleared
1,179
First cleared
Most recent

FDA classification definition

“A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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 LZA under 21 CFR 880.6250, via openFDA

Market context for product code LZA

FDA has cleared 1,179 devices under product code LZA between 1984 and 2026, filed by 498 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 LZA

Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LZA

1–100 of 1,179

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