• 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 K212438
Device Name Comfortpro
Thai Rubber Industry Company Limited
738 Moo 5, Manam Koo
Pluakdaeng,  TH 21140
Applicant Contact Chawalit Tiyadechachai
Liberty Management Group Ltd.
75 Executive Dr. STE 114,
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number880.6250
Classification Product Code
Date Received08/04/2021
Decision Date 12/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No