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 K062715
Device Name SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW
Applicant
Baoding Guanzhong Glove Co., Ltd.
10 Seton Court
Rancho Mirage,  CA  92270
Applicant Contact MARY A DOUCETTE
Correspondent
Baoding Guanzhong Glove Co., Ltd.
10 Seton Court
Rancho Mirage,  CA  92270
Correspondent Contact MARY A DOUCETTE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/11/2006
Decision Date 11/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-