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 K152707
Device Name Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
Applicant
MINGHAO MEDICAL PRODUCTS CO.,LTD.
WEST INDUSTRIAL PARK, LUANNAN COUNTY
TANGSHAN,  CN 063500
Applicant Contact PANG CUIRU
Correspondent
CHU XIAOAN
Room 1606 Bldg. 1 Jianxiang Yuan No 209 Bei Si Huan Zhong Rd
Haidian Dis
Beijing,  CN 100083
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received09/21/2015
Decision Date 03/17/2016
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
-
-