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 K982806
Device Name CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
Applicant
PERUSAHAAN GETAH ASAS SDN BHD
LOT 754, JALAN HAJI SIRAT
OFF JALAN KAPAR, PO BOX 188
SELANGOR DARUL EHSAN,  MY 41720
Applicant Contact BOB CHAN
Correspondent
PERUSAHAAN GETAH ASAS SDN BHD
LOT 754, JALAN HAJI SIRAT
OFF JALAN KAPAR, PO BOX 188
SELANGOR DARUL EHSAN,  MY 41720
Correspondent Contact BOB CHAN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/11/1998
Decision Date 09/30/1998
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
-
-