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 K111772
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
Applicant
Kossan Latex Industries(M)Sdn Bhd
Lot 6129,Jalan Haji Abdul
Manan, Off Jalan Meru
Klang, Selangor D.E.,  MY 41050
Applicant Contact CHO SOW FONG
Correspondent
Kossan Latex Industries(M)Sdn Bhd
Lot 6129,Jalan Haji Abdul
Manan, Off Jalan Meru
Klang, Selangor D.E.,  MY 41050
Correspondent Contact CHO SOW FONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/23/2011
Decision Date 10/20/2011
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
-
-