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 Medical Glove, Specialty
510(k) Number K895781
Device Name ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
Applicant
Ansell Intl.
Lot 80, Air Keroh Ind. Est.
Melaka,  MT 75150
Applicant Contact PAUL CACIOLI
Correspondent
Ansell Intl.
Lot 80, Air Keroh Ind. Est.
Melaka,  MT 75150
Correspondent Contact PAUL CACIOLI
Regulation Number880.6250
Classification Product Code
LZC  
Date Received09/27/1989
Decision Date 03/09/1990
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
-
-