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 K033835
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
Applicant
Mdm Enterprise Corp.
7668 Belpine Pl.
Rancho Cucamonga,  CA  91730
Applicant Contact ELIZABETH DENG
Correspondent
Mdm Enterprise Corp.
7668 Belpine Pl.
Rancho Cucamonga,  CA  91730
Correspondent Contact ELIZABETH DENG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/10/2003
Decision Date 01/22/2004
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
-
-