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 latex patient examination glove
510(k) Number K161006
Device Name Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
Applicant
HARTALEGA SDN. BHD.
DATARAN SD PJU 9
BANDAR SRI DAMANSARA,  MY 52200
Applicant Contact KUAN KAM HON
Correspondent
HARTALEGA SDN. BHD.
NO. 7 KAWASAN PERUSAHAAN SURIA
BESTARI JAYA,  MY 45600
Correspondent Contact NURUL AISYAH KONG BT ABDULLAH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/11/2016
Decision Date 08/04/2016
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
-
-