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 K051778
Device Name NITRILE POWDERED EXAMINATION GLOVES (BLUE)
Applicant
HARTALEGA SDN BHD
9 JALAN KUANG BULAN TAMAN
KEPONG INDUSTRIAL ESTATE
KUALA LUMPUR,  MY 52100
Applicant Contact KUAN KAM HON
Correspondent
HARTALEGA SDN BHD
9 JALAN KUANG BULAN TAMAN
KEPONG INDUSTRIAL ESTATE
KUALA LUMPUR,  MY 52100
Correspondent Contact KUAN KAM HON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/01/2005
Decision Date 07/26/2005
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
-
-