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 K212916
Device Name Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Applicant
Rimba Glove SDN BHD
Plot 37, Medan Tasek, Tasek Industrial Area,
IPOH,  MY 31400
Applicant Contact Zahari Bin Darus
Correspondent
Emergo Global Representative LLC,
2500 Bee Cave Road Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Michael Van Der Woude
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/13/2021
Decision Date 03/24/2022
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
-
-