Product code LZA

Device name

Polymer Patient Examination Glove

Medical specialty

General Hospital

Device class

1

Regulation number

880.6250

Review panel

HO

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset