• 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 K220232
Device Name Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
Megine Industries Sdn Bhd
B-05-02, The Vertical Business Suites, 8,
Jalan Kerinchi, Bangsar South
Kuala Lumpur,  MY 59200
Applicant Contact Benjamin Ng Soong Jing
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number880.6250
Classification Product Code
Date Received01/27/2022
Decision Date 02/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party Yes
Combination Product No