Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Latex Patient Examination Glove
510(k) Number K110250
Device Name MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
Applicant
Total Gloves Sdn Bhd
Kamunting Industrial Estate
Kamunting
Taiping, Perak,  MY 34600
Applicant Contact OOI LOON SENG
Correspondent
Total Gloves Sdn Bhd
Kamunting Industrial Estate
Kamunting
Taiping, Perak,  MY 34600
Correspondent Contact OOI LOON SENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/28/2011
Decision Date 10/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-