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 K991690
Device Name LATEX EXAMINATION GLOVES (PRE POWDERED)
Applicant
Usg Healthguard Sdn Bhd
Lot 2756 Jalan Kempas Lama
(Off 8 Miles Jalan Skudai)
Skudai, Johor Bahru, Johor,  MY 81300
Applicant Contact TOH CHEE YEONG
Correspondent
Usg Healthguard Sdn Bhd
Lot 2756 Jalan Kempas Lama
(Off 8 Miles Jalan Skudai)
Skudai, Johor Bahru, Johor,  MY 81300
Correspondent Contact TOH CHEE YEONG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/18/1999
Decision Date 06/24/1999
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
-
-