• 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 K211904
Device Name Vinyl Glove
Jiangsu Dihong Industry and Trade Co., Ltd.
Dongxiaodian Industrial Park
Shuyang,  CN 223616
Applicant Contact Sue Chen
Shanghai Truthful Information Technology Co., Ltd.
RM.608, No.738,Shangcheng Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
Date Received06/21/2021
Decision Date 09/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No