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 K123469
Device Name POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
Applicant
Wear Safe (Malaysia) Sdn Bhd - Facility II
Lot 63616, Pt 54924, No 3, Jalan Korporat 7c/Ku9
Taman Perindustrian Meru
Mukim Kapar, Klang, Selangor,  MY 42200
Applicant Contact ALEX YOONG
Correspondent
Wear Safe (Malaysia) Sdn Bhd - Facility II
Lot 63616, Pt 54924, No 3, Jalan Korporat 7c/Ku9
Taman Perindustrian Meru
Mukim Kapar, Klang, Selangor,  MY 42200
Correspondent Contact ALEX YOONG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/13/2012
Decision Date 02/19/2013
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
-
-