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 K120798
Device Name DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR
Applicant
Canopus Medical Supply Co., Ltd.
18709 Green Bat Dr.,
Rowland Highs,  CA  91748
Applicant Contact GLORIA CHANG
Correspondent
Canopus Medical Supply Co., Ltd.
18709 Green Bat Dr.,
Rowland Highs,  CA  91748
Correspondent Contact GLORIA CHANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/15/2012
Decision Date 05/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-