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 K161944
Device Name Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
Applicant
Shandong Baisheng Medical Products Co., Ltd.
11 Longshan Rd., Wolong Industy Park
Linqu,  CN 262600
Applicant Contact CECILY SHENG
Correspondent
Basic Medical Industries., Inc.
805 Barrington Ave.
Ontario,  CA  91764
Correspondent Contact JOHN ZHAO
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received07/15/2016
Decision Date 11/21/2016
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
Predetermined Change
Control Plan Authorized		 No
-
-