LZC

Medical Glove, Specialty

Product code
LZC
Device name
Medical Glove, Specialty
Device class
Class 1
21 CFR
21 CFR 880.6250
Medical specialty
General Hospital
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
79 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-01-14.

NumberDecision dateApplicantDevice nameSummary
K2523132026-01-14CardinalhealthCardinal Health Nitrile Examination Gloves Extended …
K2439592025-02-24Lingshi Hongruida Health Protection Te…Powder Free Nitrile Examination Gloves (Violet, Blac…PDF

1 summaries are archived here for direct download.

Official FDA classification page: LZC
Classification and pathway per current FDA publications. Data from openFDA (CC0).