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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 420-0113322-4/2/1


Manufacturer FEI3002327142
Manufacturer NameZhenjiang Kangda Emulsion Co,Ltd  
Manufacturer Address line 1Huang Shan Tao  
Manufacturer Address line 2  
Manufacturer's CityYangzhong  
Manufacturer Province/StateJinagsu  
Manufacturer Country/AreaChina  
Product Code80LZA  
FDA Product DescriptionGLOVE, PATIENT EXAMINATION, POLY  
Refusal Date29-Nov-2011  
FDA DistrictMIN-DO  
Entry/doc/line/sfx 420-0113322-4/2/1
FDA Sample AnalysisYes  
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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