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 K903351
Device Name PROLAX DISPOSABLE LATEX GLOVES (PROCEDURE STERILE)
Applicant
Prolax Medical Products, Inc.
60 Cutter Mill Rd.
Suite 514
Great Neck,  NY  11021
Applicant Contact LEO MINDICK
Correspondent
Prolax Medical Products, Inc.
60 Cutter Mill Rd.
Suite 514
Great Neck,  NY  11021
Correspondent Contact LEO MINDICK
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/26/1990
Decision Date 09/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-