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 Polymer Patient Examination Glove
510(k) Number K003563
Device Name POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
Applicant
Ning BO Yujiang Rubber & Plastic Co.
1998 Ave. De La D'Emerald
Sparks,  NV  89434
Applicant Contact JANNA P TUCKER
Correspondent
Ning BO Yujiang Rubber & Plastic Co.
1998 Ave. De La D'Emerald
Sparks,  NV  89434
Correspondent Contact JANNA P TUCKER
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/20/2000
Decision Date 01/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-