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 K220118
Device Name Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
Applicant
Kl-Kepong Rubber Products Sdn. Bhd.
Lot 134905, ¾ Mile Off Jalan Bercham
Kawasan Perindustrian Bercham
Ipoh,  MY 31400
Applicant Contact Cheng Phooi Yann
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Kewin Tham
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received01/14/2022
Decision Date 05/12/2022
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
-
-