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 vinyl patient examination glove
510(k) Number K032630
Device Name DISPOSABLE POWDER FREE VINYL EXAM GLOVES
Applicant
KINGSWELL INTERNATIONAL INC.
264 CARBONIA AVE.
WALNUT,  CA  91789
Applicant Contact D.C. CHANG
Correspondent
KINGSWELL INTERNATIONAL INC.
264 CARBONIA AVE.
WALNUT,  CA  91789
Correspondent Contact D.C. CHANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received08/26/2003
Decision Date 10/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-