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 K011924
Device Name POWDERED BLUE NITRILE EXAMINATION GLOVES
Applicant
Seltom Pacific Sdn. Bhd.
Lot 25, Jalan Pjs 7/17
Sunway Industrial Park
Petaling Jaya, Selangor,  MY 46150
Applicant Contact S SEGARAN
Correspondent
Seltom Pacific Sdn. Bhd.
Lot 25, Jalan Pjs 7/17
Sunway Industrial Park
Petaling Jaya, Selangor,  MY 46150
Correspondent Contact S SEGARAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/20/2001
Decision Date 07/10/2001
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
-
-