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 K131440
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
Applicant
Hebei Hongsen Plastics Technology Co, Ltd.
5 Carey St.
Pennington,  NJ  08534
Applicant Contact CHARLES SHEN
Correspondent
Hebei Hongsen Plastics Technology Co, Ltd.
5 Carey St.
Pennington,  NJ  08534
Correspondent Contact CHARLES SHEN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/20/2013
Decision Date 09/25/2013
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 Yes
Predetermined Change
Control Plan Authorized		 No
-
-