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Powder-Free Guayle Rubber Examination Glove

FDA product code OIG · 1 cleared devices

Class 1 General Hospital
Regulation
21 CFR 880.6250
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2008-04-18 – 2008-04-18

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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