LZC

79 FDA 510(k) clearances · Product code

FDA profile

Official device name

Medical Glove, Specialty

Device class

Class I (low risk)

Regulation

21 CFR 880.6250

Medical specialty

General Hospital

Flags

Third-party review eligible

FDA 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.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free