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 surgeon's gloves
510(k) Number K171047
Device Name Sterile Polyisoprene Powder Free Surgical Gloves
Applicant
Better Care Plastic Technology Co.,Ltd.
Fuqian Xi Road, West District of Shenze Industrial Base
Shenze County,  CN 050000
Applicant Contact Zhu Chunyan
Correspondent
Hongray USA Medical Products Inc
2235 E Francis St
Ontario,  CA  91761
Correspondent Contact Kathy Liu
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/07/2017
Decision Date 06/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-