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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 525-0796083-0/1/1

Manufacturer FEI3008386557
Manufacturer NameZibo Yinghao Medical Products Co., Ltd.  
Manufacturer Address line 1No. 6 Yifan Road  
Manufacturer Address line 2Technology Industry Park  
Manufacturer's CityZibo  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code80LYZ  
Importer's Product DescriptionPOWDER FREE VINYL EXAM GLOVES  
Refusal Date29-Mar-2011  
FDA DistrictNWE-DO  
Entry/doc/line/sfx 525-0796083-0/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
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.