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 K142588
Device Name Nitrile Powder Free Examination Glove (Blue)
Applicant
Hartalega Sdn Bhd
Dataran Sd Pju9
Bandar Sri Damansara,  MY 52200
Applicant Contact KUAN KAM HON
Correspondent
Hatalega Sdn. Bhd.
# 7, Kawasan Perusahaan Suria
Bestari Jaya,  MY 45600
Correspondent Contact NURUL AISYAH KONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/15/2014
Decision Date 12/18/2014
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
-
-