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 K031134
Device Name DISPOSABLE POWDERED VINYL EXAM GLOVES
Applicant
ELITE INTERNATIONAL, INC.
18709 GREENBAY DR.
ROWLAND HEIGHTS,  CA  91748
Applicant Contact BOBBY LING
Correspondent
ELITE INTERNATIONAL, INC.
18709 GREENBAY DR.
ROWLAND HEIGHTS,  CA  91748
Correspondent Contact BOBBY LING
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/09/2003
Decision Date 05/20/2003
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
-
-