• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Refusal Details as Recorded in OASIS by FDA

for Refusal D52-0946844-1/1/3


Manufacturer FEI3008840959
Manufacturer NameCURON SCIENTIFIC CO LTD  
Manufacturer Address line 1NO.6-2 XINGAN ROAD EAST LINQU  
Manufacturer Address line 2  
Manufacturer's CityWEIFANG  
Manufacturer Province/StateSHANDONG  
Manufacturer Country/AreaChina  
Product Code80LYZ  
FDA Product DescriptionGLOVE, PATIENT EXAMINATION, VINYL  
Refusal Date19-Nov-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx D52-0946844-1/1/3
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.  
-
-