Product code OIG

Device name

Powder-Free Guayle Rubber 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 disposable patient examination glove made from guayule natural rubber latex. This alternative source of natural rubber latex (guayale) does not contain the same protein associated with allergic reactions to latex products from the hevea rubber tree. This device 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