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 K142685
Device Name NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
Applicant
Siam Sempermed Corp., Ltd.
10 Soi 10 Phetkasem Rd.
Hatyai,  TH 90110
Applicant Contact ANAN PRUKSANUSAK
Correspondent
Sempermed USA, Inc.
13900 49th St. N.
Clearwater,  FL  33762
Correspondent Contact JOHN CALHOUN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/22/2014
Decision Date 02/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-