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 K041848
Device Name POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
Applicant
Pt. Smartglove Indonesia
Kawasan Industri Medan Star Jl
Raya Medan-Lubuk Pakam Km.19
Tg Morawa-Deli Serdang,  ID 20362
Applicant Contact FOO KHON PU
Correspondent
Pt. Smartglove Indonesia
Kawasan Industri Medan Star Jl
Raya Medan-Lubuk Pakam Km.19
Tg Morawa-Deli Serdang,  ID 20362
Correspondent Contact FOO KHON PU
Regulation Number880.6250
Classification Product Code
LZA  
Date Received07/08/2004
Decision Date 08/20/2004
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
-
-