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 vinyl patient examination glove
510(k) Number K093264
Device Name VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
Applicant
QINGDAO LANG HUI IMPORT & EXPORT CO., LTD
SHANDONG INTERNATIONAL TRADE
MANSION 51 TAIPING
QINGDAO, SHANDONG,  CN 266000
Applicant Contact MARSHAL MA
Correspondent
QINGDAO LANG HUI IMPORT & EXPORT CO., LTD
SHANDONG INTERNATIONAL TRADE
MANSION 51 TAIPING
QINGDAO, SHANDONG,  CN 266000
Correspondent Contact MARSHAL MA
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/19/2009
Decision Date 05/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-