OIG

Powder-Free Guayle Rubber Examination Glove

Product code

OIG

Device name

Powder-Free Guayle Rubber Examination Glove

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 (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

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