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 Polymer Patient Examination Glove
510(k) Number K994246
Device Name OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
Applicant
OMNIGRACE LTD.
7815 VANDERBILT DRIVE NW
NORTH CANTON,  OH  44720
Applicant Contact WILLIAM E PATTON
Correspondent
OMNIGRACE LTD.
7815 VANDERBILT DRIVE NW
NORTH CANTON,  OH  44720
Correspondent Contact WILLIAM E PATTON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received12/16/1999
Decision Date 01/31/2000
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
Predetermined Change
Control Plan Authorized		 No
-
-