OIG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Powder-Free Guayle Rubber Examination Glove

Device class

Class I (low risk)

Regulation

21 CFR 880.6250

Medical specialty

General Hospital

Flags

Third-party review eligible

FDA 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.

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