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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
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

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Particulates 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 2 2
Swelling 2 2
Heart Failure 1 1
Anaphylactoid 1 1
Complaint, Ill-Defined 1 1
Disability 1 1
Reaction 1 1
Neurological Deficit/Dysfunction 1 1
Rash 1 1
Skin Irritation 1 1

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