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 K992523
Device Name HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W
Applicant
PAMITEX INDUSTRIES SDN BHD
2 1/2 MILES, JALAN RASAH
SEREMBAN, NAGERI SEMBILAN
DARUL KHUSUS,  MY 70300
Applicant Contact SAID AWANG
Correspondent
PAMITEX INDUSTRIES SDN BHD
2 1/2 MILES, JALAN RASAH
SEREMBAN, NAGERI SEMBILAN
DARUL KHUSUS,  MY 70300
Correspondent Contact SAID AWANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/28/1999
Decision Date 10/18/1999
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
-
-