David Lim

FDA Filings

This page includes the latest FDA filings for David Lim. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003851058
FEI Number3003851058
NameDAVID LIM
Owner & OperatorTOP GLOVE MEDICAL (THAILAND) CO., LTD.
Contact Address188 Moo-5 Karnchanawanich Rd. Tambon Sumnakkham
Amphur Sadao TH-90 Songkhla 90320 TH
Official Correspondent
  • SAW - ENG KOOI
  • 66-74-410000-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address165 N Aspan Ave
Azusa, CA 91702 US
Establishment TypeManufacture Medical Device



Registration Number3005689707
FEI Number3005689707
NameDavid Lim
Owner & OperatorAdventa Health Sdn Bhd
Contact Address1, Jalan 8 Pengkalan Chepa 2 Industrial Zone
Kota Bharu MY-03 Kelantan 16100 MY
Official Correspondent
  • Lee Kim Meow
  • 60-9-7747171-x
US Agent
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
Importing Logistics Registration
ImporterTRADEX INTERNATIONAL, INC
Address3651 BIRCHWOOD DRIVE
Waukegan, IL 60085 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address165 N. Aspan Ave
Azusa, CA 91702 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3005374243
FEI Number3005374243
NameDavid Lim
Owner & OperatorFLEXITECH SDN. BHD.
Contact AddressLOT 124 & 126, JALAN LAPAN KOMPLEKS OLAK LEMPIT
BANTING MY-10 Selangor 42700 MY
Official Correspondent
  • SIOW CHUN MIN
  • 60-3-31491998-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
ImporterTG MEDICAL (USA), INC
Address165 NORTH ASPEN AVE.
Azusa, CA 91702 UNITED STATES
Importer TypeAgent
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)



Registration Number9616824
FEI Number3003195447
NameDavid Lim
Owner & OperatorDuramedical Sdn Bhd
Contact AddressLot 4962, Jalan Teratai, Batu 6, Off Jal
Klang MY-10 Selangor 41050 MY
Official Correspondent
  • Ong Ah Chye
  • 60-3-78903339-x
US Agent
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address165 N.Aspen Ave
Azusa, CA 91702 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



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



Registration Number9680622
FEI Number3002808366
NameDavid Lim
Owner & OperatorTG MEDICAL SDN BHD
Contact AddressLOT 5091, JALAN TERATAI, BT 5, OFF JALAN MERU
KLANG MY-10 Selangor 41050 MY
Official Correspondent
  • LIM - WEE-CHAI
  • 60-3-33927880-x
US Agent
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
Importing Logistics Registration
ImporterGorilla Paper Inc
Address1125 Lunt Ave.
Elk Grove Village, IL 60007 UNITED STATES
Importing Logistics Registration
ImporterSEATTLE GLOVE INC
Address11524 CYRUS WAY
Mukilteo, WA 98275 UNITED STATES
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)



Registration Number3005478020
FEI Number3005478020
NameDavid Lim
Owner & OperatorGREAT GLOVE (XINGHUA) CO., LTD.
Contact AddressSOUTH OF WEIWU ROAD ECONOMIC DEVELOPMENT DISTRICT
XINGHUA, JIANGSU PROVINCE CN-32 Jiangsu 225700 CN
Official Correspondent
  • Tan Chee Hoong
  • 86-523-3268976-x
US Agent
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address165 N. Aspan Ave
Azusa, CA 91702 US
Establishment TypeManufacture Medical Device



Registration Number3006796582
FEI Number3006796582
NameDavid Lim
Owner & OperatorGMP MEDICARE SDN BHD
Contact AddressLot/PT 64593, Jalan Dahlia/KU8, Kawasan Perindustrian Meru Timur
Klang MY-10 Selangor 41050 MY
Official Correspondent
  • WONG CHONG BAN
  • 60-3-33926317-x
US Agent
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
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



Registration Number8040898
FEI Number3002700151
NameDavid Lim
Owner & OperatorTERANG NUSA SDN BHD
Contact Address1, Jalan 8, Pengkalan Chepa 2 Industrial Zone
Kota Bharu MY-03 Kelantan 16100 MY
Official Correspondent
  • Lee Shin Hwai
  • 60-9-7747171-x
US Agent
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address165 N. Aspan Ave
Azusa, CA 91702 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
David Lim [TERANG NUSA SDN BHD]
Nugard Black2017-08-17
David Lim [TERANG NUSA SDN BHD]
Powder Free Polychloroprene Examination Glove Pink2016-11-28
David Lim [TERANG NUSA SDN BHD]
Powder Free Polychloroprene Examination Glove Blue2016-11-28
David Lim [Adventa Health Sdn Bhd]
Powder Free Polychloroprene Examination Glove Pink2016-11-28
David Lim [Adventa Health Sdn Bhd]
Powder Free Polychloroprene Examination Glove Blue2016-11-28
David Lim [TERANG NUSA SDN BHD]
Powder Free Polychloroprene Examinatino Glove Green2016-08-15
David Lim [TERANG NUSA SDN BHD]
Nuzone X32015-09-01
David Lim [TERANG NUSA SDN BHD]
Nuzone X2G2015-09-01
David Lim [TERANG NUSA SDN BHD]
Sensiflex Plus2014-11-23
David Lim [Adventa Health Sdn Bhd]
ILLUSION POWDER FREE EXAMINATION GLOVES2014-03-19
David Lim [Adventa Health Sdn Bhd]
ILLUSION POWDER FREE EXAMINATION GLOVES VANILLA2014-03-19
David Lim [Adventa Health Sdn Bhd]
ILLUSION POWDER FREE EXAMINATION GLOVES PINK2014-03-19
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
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
David Lim [Adventa Health Sdn Bhd]
NUZONE X2T CHEMOTHERAPY2012-01-05
David Lim [Adventa Health Sdn Bhd]
NUGARD NITRILE POWDER FREE2011-11-07
David Lim [Adventa Health Sdn Bhd]
NUGARD NITRILE GREY PF2011-05-03
David Lim [Adventa Health Sdn Bhd]
TRIFLEX 2D7250 SERIES2011-02-15
David Lim [TERANG NUSA SDN BHD]
NUGARD NITRILE GREY PF2011-02-14
David Lim [Adventa Health Sdn Bhd]
NUGARD NITRILE2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT WHITE NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT PINK NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT BLUE NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
NUGARD NITRILE2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT WHITE NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT PINK NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT BLUE NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
NUGARD NITRILE2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT WHITE NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT PINK NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT BLUE NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
NUGARD NITRILE2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT WHITE NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT PINK NITRILE EXAM GLOVES2011-02-07
David Lim [Adventa Health Sdn Bhd]
ELEGANT BLUE NITRILE EXAM GLOVES2011-02-07
David Lim [TERANG NUSA SDN BHD]
Vet One2010-09-01
David Lim [TERANG NUSA SDN BHD]
Uniseal2010-09-01
David Lim [TERANG NUSA SDN BHD]
TRIFLEX2010-09-01
David Lim [TERANG NUSA SDN BHD]
SUR-G-GLOV POWDER2010-09-01
David Lim [TERANG NUSA SDN BHD]
PSS SELECT2010-09-01
David Lim [TERANG NUSA SDN BHD]
OR CLASSIC2010-09-01
David Lim [TERANG NUSA SDN BHD]
MAXITEX POWDER2010-09-01
David Lim [Adventa Health Sdn Bhd]
SUR-G GLOVE POWDER2010-09-01
David Lim [Adventa Health Sdn Bhd]
MAXITEX POWDER2010-09-01
David Lim [TERANG NUSA SDN BHD]
NUGARD NITRILE PF2009-12-15
David Lim [Adventa Health Sdn Bhd]
SENSIFLEX2009-07-23
David Lim [Adventa Health Sdn Bhd]
POWDER FREE LATEX EXAMINATION PATIENT GLOVES2009-07-23
David Lim [Adventa Health Sdn Bhd]
SENSIFLEX POWDERFREE2009-07-23
David Lim [Adventa Health Sdn Bhd]
SENSIFLEX2009-07-23
David Lim [Adventa Health Sdn Bhd]
SENSIFLEX PLUS2009-07-23
David Lim [Adventa Health Sdn Bhd]
MAXITEX PF2009-07-23
David Lim [Adventa Health Sdn Bhd]
PATIENT EXAMINATION GLOVES (LATEX)2009-07-23
David Lim [Adventa Health Sdn Bhd]
NUGARD2009-07-23
David Lim [Adventa Health Sdn Bhd]
Nugard2009-07-23
David Lim [Adventa Health Sdn Bhd]
NUGARD LATEX POWDER2009-07-23
David Lim [Adventa Health Sdn Bhd]
SENSIFLEX POWDER FREE PROCEDURE2009-07-23
David Lim [Adventa Health Sdn Bhd]
NUGARD POWDER PROCEDURE2009-07-23
David Lim [Adventa Health Sdn Bhd]
NUZONE X2 POLYISOPRENE-POLYCHLOROPRENE POWDER FREE2009-07-23
David Lim [Adventa Health Sdn Bhd]
ILLUSION POWDER FREE BUBBLE GUM BLUE2009-07-23
David Lim [Adventa Health Sdn Bhd]
ILLUSION POWDER FREE GRAPE BLUE2009-07-23
David Lim [Adventa Health Sdn Bhd]
SENSIFLEX2009-07-23
David Lim [Adventa Health Sdn Bhd]
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES2009-07-23
David Lim [Adventa Health Sdn Bhd]
NUGARD POWDER FREE BLUE2009-07-23
David Lim [Duramedical Sdn Bhd]
DURADAM2008-12-28
David Lim [TG MEDICAL SDN BHD]
TG MEDICAL2008-06-20
David Lim [TG MEDICAL SDN BHD]
TG MEDICAL2008-06-20
David Lim [TG MEDICAL SDN BHD]
TG MEDICAL2008-06-20
David Lim [TG MEDICAL SDN BHD]
TG MEDICAL2008-06-20
David Lim [TERANG NUSA SDN BHD]
Uniseal Sensiflex Plus2007-11-09
David Lim [TERANG NUSA SDN BHD]
TRIUMP LT2007-11-09
David Lim [TERANG NUSA SDN BHD]
SENSIFLEX2007-11-09
David Lim [TERANG NUSA SDN BHD]
SENSIFLEX PLUS2007-11-09
David Lim [TERANG NUSA SDN BHD]
PSS SELECT2007-11-09
David Lim [TERANG NUSA SDN BHD]
PSS POLYISOPRENE - POLYCHLOROPRENE POWDER-FREE2007-11-09
David Lim [TERANG NUSA SDN BHD]
NUZONE X2 POLYISOPRENE - POLYCHLOROPRENE POWDER FREE2007-11-09
David Lim [TERANG NUSA SDN BHD]
Fusione2007-11-09
David Lim [TERANG NUSA SDN BHD]
NUGARD POWDER FREE BLUE2007-11-09

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