• 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 K122131
Model SIZE XS,S,M,L, AND XL
Device Name POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
Original Applicant
MATANG MFG. SDN. BHD.
lot 10, kawasan perindustrian
serkam, mukim serkam
merlimau, melaka,  MY 77300
Original Contact leslie leong
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received07/18/2012
Decision Date 10/17/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-