Koon Seng Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Koon Seng 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 Number8040793
FEI Number3003218972
NameKOON SENG SDN.BHD
Owner & OperatorKOON SENG SDN.BHD
Contact AddressPTD 3274, BATU 4 1/2, JALAN BAKRI,
MUAR, ,JOHOR MY-NOTA 84000 MY
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPTD 3274 BATU 4 1/2 JALAN BAKRI
MUAR Johor, 84000 MY
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3008509176
FEI Number3008509176
NameAlan Schwartz
Owner & OperatorKOON SENG SDN.BHD
Contact AddressPTD 3274, BATU 4 1/2, JALAN BAKRI,
MUAR, ,JOHOR MY-NOTA 84000 MY
US Agent
Importing Logistics Registration
ImporterADI Medical
Address1565 South Shields Drive
Waukegan, IL 60085 UNITED STATES
Phone1 857 6889968
Importing Logistics Registration
ImporterAMERILINE Healthcare LLC
Address3815 Victoria De
West Palm Beach, FL 33406 UNITED STATES
Importing Logistics Registration
ImporterAsia Dynamics (Group) Inc.
Address1565 South Shields Drive
Waukegan, IL 60085 UNITED STATES
Importing Logistics Registration
ImporterBlueJay Dental
Address3 Sylvan Circle
Norwood, MA 02062 UNITED STATES
Phone1 617 6970301
Importing Logistics Registration
ImporterCypress Medical Products LLC
Address9954 Mayland Dr
Richmond, VA 23233 UNITED STATES
Importing Logistics Registration
ImporterGlovemed Inc
Address1090 Rocky Mountain Rd
Big Bear City, CA 92314 UNITED STATES
Importing Logistics Registration
ImporterShield Line LLC
Address1 University Plaza Dr Suite 514
Hackensack, NJ 07601 UNITED STATES
Importing Logistics Registration
ImporterTRADEX INTERNATIONAL INC A CARDINAL HEALTH COMPANY
Address3651 Birchwood Dr. Waukegan
Park City, IL 60085 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address55 Northern Blvd
Great Neck, NY 11021 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Alan Schwartz [KOON SENG SDN.BHD]
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)2018-05-16
Alan Schwartz [KOON SENG SDN.BHD]
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)2018-05-16
Koon Seng Sdn. Bhd.
KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs (Blue, Black)2018-02-22
KOON SENG SDN.BHD
Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)2012-06-19
KOON SENG SDN.BHD
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE2012-06-19
Alan Schwartz [KOON SENG SDN.BHD]
Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)2012-06-19
Alan Schwartz [KOON SENG SDN.BHD]
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE2012-06-19
KOON SENG SDN.BHD
Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue2011-07-15
Alan Schwartz [KOON SENG SDN.BHD]
Royal Imperial Nitrile Examination Gloves Textured Powder-Free Blue2011-07-15
KOON SENG SDN.BHD
ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE2011-07-14
KOON SENG SDN.BHD
KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)2009-12-02
KOON SENG SDN.BHD
ROYAL IMEPRIAL Powdered Latex Examination Gloves with Protein Control Labeling Claim (200 Micrograms or Less)2008-10-20
Alan Schwartz [KOON SENG SDN.BHD]
ROYAL IMEPRIAL Powdered Latex Examination Gloves with Protein Control Labeling Claim (200 Micrograms or Less)2008-10-20
KOON SENG SDN.BHD
Royal Imperial Powder Free Polymer Coated Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or2007-11-09
Alan Schwartz [KOON SENG SDN.BHD]
Royal Imperial Powder Free Polymer Coated Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or2007-11-09
KOON SENG SDN.BHD
ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)2001-12-07
KOON SENG SDN.BHD
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR2001-10-31
KOON SENG SDN.BHD
PATIENT EXAMINATION GLOVES (LATEX)1989-05-31

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092965586Yantian,China (Mainland) -> Tacoma, Washington1X40HQ CONTAINER CONTAINING:- 2,843 CARTONS OF NITRILE EXAMINATION GLOVES POWDER FREE, FINGER TEXTURED, BLUE, NON-STERILE PACKED 1,000PCS PER CARTON . HANDYMAN2843 CTN
2020092858002Yantian,China (Mainland) -> Tacoma, Washington1X40HQ CONTAINER CONTAINING:- 2,843 CARTONS OF NITRILE EXAMINATION GLOVES POWDER FREE, FINGER TEXTURED, BLUE, NON-STERILE PACKED 1,000PCS PER CARTON . HANDYMAN2843 CTN
2020092832808Xiamen,China (Mainland) -> Los Angeles, CaliforniaCARTON OF LATEX GLOVES POWDER, SMOOTH, NON-S TERILE PACKED 100PCS-BOX 6 BOXES-CARTON5751 CTN
2020080646573Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaSHIPPERS SAID TO CONTAIN 1 X 40HC CONTAINER STC 1242 CASES OF LATEX EXAMINATION GLOVES P OWDER FREE POLYMER COATED TEXTURES NONSTERILE PACKED 2000PCS PER CASE PUREBLISS SIZE XSM ALL 150 CASES SMALL 530 CASES MEDIUM 427 C ASES LARGE 11242 CAS
2020072334188Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaSHIPPERS LOAD AND COUNT 1 X 40HC CONTAINER S TC 1242 CASES OF LATEX EXAMINATION GLOVES P OWDER FREE POLYMER COATED TEXTURED NONSTERILE PACKED 2000PCS PER CASE. PURESKIN SIZE XSMA LL 150 CASES SMALL 530 CASES M1242 CAS
2020061922706Kaohsiung,China (Taiwan) -> Tacoma, Washington1X40GP CONTAINER CONTAINING 2000 CARTONS OF NITRILE GLOVES POWDER FREE FINGER TEXTURED BLUE NON STERILE PACKED 1000PCS PER CARTON PO 319582000 CTN
2020052913555Singapore,Singapore -> Los Angeles, CaliforniaCONFIDERM 3.8 PFT NITRLGLV MED OF NITRILE GLOVES POWDER FREE, FINGER TEXTURED, BLUE NON-STERILE PACKED 1,000 PCS PER CARTON CONFIDERM3437 PCS
2020050413246Singapore,Singapore -> Los Angeles, CaliforniaRUBBER GLOVE2785 CTN

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