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 K111297
Device Name SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
Applicant
Premier Medical Gloves Factory
# 8-2, Xing'An Rd.,
Dongcheng, Linqu
Weifang, Shandong,  CN 262600
Applicant Contact LIANG ZHAO
Correspondent
Premier Medical Gloves Factory
# 8-2, Xing'An Rd.,
Dongcheng, Linqu
Weifang, Shandong,  CN 262600
Correspondent Contact LIANG ZHAO
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/09/2011
Decision Date 06/16/2011
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
-
-