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 Latex Patient Examination Glove
510(k) Number K081488
Device Name POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Applicant
Pt. Maja Agung Latexindo
5445 Daniels St.
Chino,  CA  91710
Applicant Contact EMMY TJOENG
Correspondent
Pt. Maja Agung Latexindo
5445 Daniels St.
Chino,  CA  91710
Correspondent Contact EMMY TJOENG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/28/2008
Decision Date 08/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-