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 K031754
Device Name FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
Applicant
PT. MANDIRI INTI BUANA
JL. LISTRIK NO. 6
MEDAN,  ID 20112
Applicant Contact NG POY SIN
Correspondent
PT. MANDIRI INTI BUANA
JL. LISTRIK NO. 6
MEDAN,  ID 20112
Correspondent Contact NG POY SIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/31/2003
Decision Date 06/30/2003
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
-
-