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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal BEA-9223230-1/2/2


Manufacturer FEI1000254914
Manufacturer NameZhangjiagang Dayu Rubber Products Co., Ltd.  
Manufacturer Address line 1Xizhang Town  
Manufacturer Address line 2  
Manufacturer's CityZhangjiagang City  
Manufacturer Province/StateJiangsu  
Manufacturer Country/AreaChina  
Product Code80LYY  
FDA Product DescriptionGLOVE, PATIENT EXAMINATION, LATEX  
Refusal Date29-Nov-2011  
FDA DistrictCHI-DO  
Entry/doc/line/sfx BEA-9223230-1/2/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
HOLES   501(c); 801(a)(3) Adulteration   The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.  
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