Top Glove Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Top Glove Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number8043848
FEI Number3003564842
NameDavid Lim
Owner & OperatorTOP GLOVE SDN. BHD.
Contact AddressLOT 4969, JALAN TERATAI, BATU 6 OFF JALAN MERU
KLANG MY-10 Selangor 41050 MY
Official Correspondent
  • TONG SIEW - BEE
  • 60-3339-21992-x
US Agent
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
Importing Logistics Registration
ImporterCARDINAL HEALTH 200, LLC
Address1430 WAUKEGAN ROAD
Waukegan, IL 60085 UNITED STATES
Importing Logistics Registration
ImporterCYPRESS MEDICAL PRODUCTS LLC
Address1202 S II ROUTE 31
McHenry, IL 60050 UNITED STATES
Importing Logistics Registration
ImporterTG MEDICAL (USA), INC
Address165 NORTH ASPEN AVE.
Azusa, CA 91702 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address165 N. Aspan Ave
Azusa, CA 91702 US
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Top Glove SDN BHD
Latex Examination Powder Free Glove, Aloe Vera2020-06-05
Top Glove Sdn. Bhd.
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue2018-04-26
Top Glove SDN BHD
Sterile Nitrile Surgical Powder Free Gloves Tested For Use With Chemotherapy Drugs And Sterile Latex Surgical Powder Free Gloves2017-10-12
David Lim [TOP GLOVE SDN. BHD.]
Patient Examination Gloves2012-12-06
David Lim [TOP GLOVE SDN. BHD.]
Patient Examination Gloves2012-12-06
David Lim [TOP GLOVE SDN. BHD.]
Black Nitrile Powder-Free Examination Gloves2012-12-03
TOP GLOVE SDN. BHD.
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS2012-11-30
David Lim [TOP GLOVE SDN. BHD.]
POLY GENERAL HOSPITAL2012-09-03
David Lim [TOP GLOVE SDN. BHD.]
PATIENT EXAMINATION2012-09-03
David Lim [TOP GLOVE SDN. BHD.]
GLOVES2012-09-03
David Lim [TOP GLOVE SDN. BHD.]
PATIENT EXAMINATION2012-05-11
David Lim [TOP GLOVE SDN. BHD.]
LATEX GENERAL HOSPITAL2012-05-11
David Lim [TOP GLOVE SDN. BHD.]
GLOVES2012-05-11
TOP GLOVE SDN. BHD.
ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES2003-02-13
TOP GLOVE SDN. BHD.
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES2000-01-11
TOP GLOVE SDN. BHD.
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES1999-12-20
TOP GLOVE SDN. BHD.
GREEN POWDERED LATEX EXAMINATION GLOVES1999-12-20
TOP GLOVE SDN. BHD.
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE1999-12-13
TOP GLOVE SDN. BHD.
POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES1999-05-20
TOP GLOVE SDN. BHD.
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING1999-04-27
TOP GLOVE SDN. BHD.
NITRILE LATEX POWDER FREE EXAMINATION GLOVE1998-12-04
TOP GLOVE SDN. BHD.
NITRILE LATEX POWDERED EXAMINATION GLOVE1998-12-04
TOP GLOVE SDN. BHD.
POWDERFREE LATEX EXAMINATION GLOVES1994-12-13
TOP GLOVE SDN. BHD.
LATEX EXAMINATION GLOVES1991-09-27

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