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

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name polymer patient examination glove
510(k) Number K120970
Device Name NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
Original Applicant
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD
rm 1606 bldg 1
jianxiang yuan no.209 bei shi huan zho
beijing,  CH ch
Original Contact chu xiaoan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/30/2012
Decision Date 07/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-