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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOIG
Regulation Number 880.6250
Device Class 1


Premarket Reviews
ManufacturerDecision
YULEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Mar-04-2011

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