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 Patient Examination Glove
510(k) Number K882583
Device Name LATEX EXAM GLOVES, NON-STERILE
Applicant
B Und J Instruments
P.O. Box 3945
City Of Industry,  CA  91744
Applicant Contact ADEN TING
Correspondent
B Und J Instruments
P.O. Box 3945
City Of Industry,  CA  91744
Correspondent Contact ADEN TING
Regulation Number880.6250
Classification Product Code
FMC  
Date Received06/22/1988
Decision Date 07/14/1988
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
-
-