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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 W69-3182507-0/1/1

Manufacturer FEI3008729422
Manufacturer NameZibo Yingjie Medical Products Co., Ltd.  
Manufacturer Address line 1No.8 West The Fifth Rd., Zhangdian  
Manufacturer Address line 2  
Manufacturer's CityZibo City  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code80LYZ  
Importer's Product DescriptionVINYL EXAM GLOVES, POWDER FREE  
Refusal Date21-Mar-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx W69-3182507-0/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FAILS STD   501(e), 801(a)(3); ADULTERATION   The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.