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 vinyl patient examination glove
510(k) Number K173017
Device Name Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Applicant
Anhui Kindguard Medical Supplies Technology Co.,Ltd
Intersection of Yulan Road and Chayang Road,
Sixian County
Suzhou,  CN 234300
Applicant Contact Chen Wei
Correspondent
Beijing Easylink CO., LTD
Rm. F302 Bldg., 41, Jing Cheng Ya Ju,
Courtyard 6 of Southern Dou Ge Zhuang,
Beijing,  CN 100121
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/27/2017
Decision Date 12/15/2017
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
-
-