• 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 K142571
Device Name Powder Free Vinyl Patient Examination Gloves
Applicant
EVER LIGHT PLASTIC PRODUCTS CO., LTD.
DONGGAO INDUSTRIAL ZONE
ZANHUANG
SHIJIAZHUANG, HEBEI,  CN 050000
Applicant Contact ZHANG LITAO
Correspondent
HONGRAY USA MEDICAL PRODUCTS INC
3973 SCHAEFER AVE.
CHINO,  CA  91710
Correspondent Contact KATHY LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/12/2014
Decision Date 12/17/2014
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
-
-