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U.S. Department of Health and Human Services

Product Classification

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Device powder-free guayle rubber examination glove
Regulation Description Patient examination glove.
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.
Physical State 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.
Technical Method 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.
Target Area The device is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeOIG
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.6250
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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