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 K122408
Device Name POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
Applicant
HONGYE PLASTIC PRODUCTS CO., LTD.
3973 SCHAFER AVE.
CHINO,  CA  91710
Applicant Contact KATHY LIU
Correspondent
HONGYE PLASTIC PRODUCTS CO., LTD.
3973 SCHAFER AVE.
CHINO,  CA  91710
Correspondent Contact KATHY LIU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/08/2012
Decision Date 01/17/2013
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 No
-
-