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 K170794
Device Name Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
Applicant
Hartalega NGC Sdn. Bhd.
# 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
Sepang,  MY 43900
Applicant Contact Kuan Mun Leong
Correspondent
Hartalega NGC Sdn. Bhd.
C-G-9, Jalan Dataran Sd 1
Dataran Sd Pju 9
Bandar Sri Damansara,  MY 52200
Correspondent Contact Nurul Aisyah Kong BT Abdullah
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received03/16/2017
Decision Date 06/30/2017
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
-
-