• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name polymer patient examination glove
510(k) Number K121526
Device Name POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
Original Applicant
SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD.
12390 east end ave.
chino,  CA  91710
Original Contact cecily sheng
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/23/2012
Decision Date 08/03/2012
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
-
-