Kossan I N T Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Kossan I N T 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 Number: 3009538921
• FEI Number: 3009538921
• Name: HAI WANG
• Owner & Operator: Kossan International Sdn Bhd
• Contact Address: Wisma Kossan,Lot 782,Jalan Sungai Putus Off Batu 3 3/4, Jalan Kapar; Klang MY-10 Selangor 42100 MY
• Official Correspondent:
  • Lim Siau Tian
  • 60-3-32910516-x
• US Agent:
  • HAI WANG
  • Parexel International
  • 301 6345515
  • 301 6348040
  • Hai.Wang@parexel.com
• Importing Logistics Registration:
  • Importer: TOTAL SOURCE MANUFACTURING
  • Address: 1445 ENGINEER ST VISTA ; Vista, CA 92081 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4600 East West Highway, Suite 350 ; Bethesda, MD 20814 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Export Device to the United States But Perform No Other Operation on Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K191800 Kossan International Sdn. Bhd.	Sterile Powder Free Nitrile Examination Glove, Blue Colored, With Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, With Non-Pyrogenic Labeling Claim	2019-09-16
PMN K190606 Kossan International Sdn. Bhd.	Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile	2019-05-28
PMN K183287 Kossan International Sdn. Bhd.	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested For Use With Chemotherapy Drugs A	2019-04-05
PMN K181857 Kossan International Sdn. Bhd.	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs And Fentanyl Citrate	2018-11-20
PMN K170397 Kossan International Sdn. Bhd.	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested For Use With Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested For Use With Chemother	2017-07-10
PMN K151750 KOSSAN INTERNATIONAL SDN. BHD.	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile	2016-08-03
PMN K160467 Kossan International Sdn. Bhd.	Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use With Chemotherapy Drugs, With Non-Pyrogenic Labeling Claim	2016-08-02
PMN K151824 KOSSAN INTERNATIONAL SDN. BHD.	Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, And Tested For Use With Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, And T	2016-08-02
PMN K143131 Kossan International Sdn. Bhd.	Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile	2015-02-12

Similar & Related FDA Registered Companies

• KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009297255	Singapore,Singapore -> Long Beach, California	GLOVES HS-CODE 401519	1800 CAS
2020092814241	Port Swettenham,Malaysia -> Long Beach, California	1,788 CASES PURCHASE ORDER NO P1133850 (KO11 ATION GLOVES, BLUE, TESTED . .	1788 CAS
202009287398	Yantian,China (Mainland) -> Los Angeles, California	NON-STERILE, POWDER FREE LATEX EXAMINATION GL .	1456 CTN
2020092824322	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	PURCHASE ORDER NO : 2570 NON- STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLORED, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE BRAND: HCS NITRILE LOW DERMA ( S-L ) --- 1,950 CASES BRAND: HCS NITRILE LOW DERMA ( XL	2050 CAS
2020092814242	Port Swettenham,Malaysia -> Long Beach, California	905 CASES PURCHASE ORDER NO P1135980 (KO0730 MINATION GLOVES, BLUE, TESTED . .	905 CAS
2020092824325	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	PURCHASE ORDER NO : 2571 NON- STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLORED, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE BRAND: HCS NITRILE LOW DERMA ( S-L ) --- 1,950 CASES BRAND: HCS NITRILE LOW DERMA ( XL	2050 CAS
2020092856223	Shanghai ,China (Mainland) -> Seattle, Washington	NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVE	3477 PKG
202009261607	Port Swettenham,Malaysia -> Tacoma, Washington	1 X 40 HC CONTAINER STC 2,150 CASES PURCHAS E ORDER NO PGA-050 NON STERILE, POWDER FREE	2150 PCS