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 K891298
Device Name AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX)
Applicant
Medi Tex, Inc.
652 Broadway
New York,  NY  10012
Applicant Contact MARK D RUSTAD
Correspondent
Medi Tex, Inc.
652 Broadway
New York,  NY  10012
Correspondent Contact MARK D RUSTAD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/13/1989
Decision Date 03/29/1989
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
-
-