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 Medical Glove, Specialty
510(k) Number K181130
Device Name Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
Applicant
Hebei Titans Hongsen Medical Technology Co., Ltd.
Eastern Industrial Zone
Nangong,  CN 051800
Applicant Contact Shaozhang Nan
Correspondent
Beijing Believe-Med Technology Services Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received04/30/2018
Decision Date 08/10/2018
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
Predetermined Change
Control Plan Authorized		 No
-
-