• 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 K211604
Device Name Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Shanxi Hongjin Plastic Technology Co., Ltd.
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County
Lifen,  CN 042300
Applicant Contact Wu Zhigang
Hongray USA Medical Products Inc.
3973 Schaefer Avenue
Chino,  CA  91710
Correspondent Contact Kathy Liu
Regulation Number880.6250
Classification Product Code
Subsequent Product Code
Date Received05/25/2021
Decision Date 10/27/2021
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