Kossan Latex Industries M Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Kossan Latex Industries M 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

3005632797

FEI Number

3005632797

Name

HAI WANG

Owner & Operator

KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

Contact Address

LOT 16632, 5 1/4 MILES, JALAN MERU
KLANG MY-10 Selangor 41050 MY

Official Correspondent

LIM - KWAN HWA
603-339-23088-x

US Agent

HAI WANG
Parexel International
301 6345515
301 6348040
Hai.Wang@parexel.com

Importing Logistics Registration

Importer	Clark Associates Inc
Address	2205, Old Philadelphia Pike, Lancaster Fertility, PA 17602 UNITED STATES
Email Address	dbrobst@clarkinc.biz
Phone	1 717 3927550
FAX	1 717 3918133

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

4600 East West Highway, Suite 350
Bethesda, MD 20814 US

Establishment Type

Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K123749 KOSSAN LATEX INDUSTRIES(M)SDN BHD	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE	2013-03-01
PMN K120066 KOSSAN LATEX INDUSTRIES(M)SDN BHD	POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL	2012-11-16
PMN K111772 KOSSAN LATEX INDUSTRIES(M)SDN BHD	POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE	2011-10-20
PMN K062764 KOSSAN LATEX INDUSTRIES(M)SDN BHD	POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED	2007-02-27
PMN K060775 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF	2006-05-16
PMN K060771 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED	2006-05-01
PMN K001557 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)	2000-06-09
PMN K001190 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE	2000-05-23
PMN K992497 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)	1999-08-25
PMN K992496 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)	1999-08-25
PMN K984020 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)	1998-12-23
PMN K984019 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS)	1998-12-23
PMN K983723 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE	1998-12-07
PMN K983721 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE	1998-12-07
PMN K970222 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	LOW PROTEIN LATEX EXAMINATION GLOVES	1997-06-24
PMN K964826 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION	1997-06-24
PMN K891417 KOSSAN LATEX INDUSTRIES (M) SDN. BHD.	PATIENT EXAMINATION GLOVES (LATEX)	1989-05-12

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090482269	Liverpool,United Kingdom -> Baltimore, Maryland	GLOVES - GLOVES KOSSAN LATEX INDUSTRIES [M] S DN. BHD. GLOVES PO 15163292 INV K2-0520/2020 HS CODE: 4015.19 FCR PKL802763	360 CTN
202008217182	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	GLOVES	1978 PKG
2020082020096	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	SHIPPERS LOAD COUNT 1 X 40HQ CONTAINER STC 3019 PACKAGES AS PER ATTACHED SHEET	3019 PKG
202008171112	Singapore,Singapore -> Tacoma, Washington	LATEX GLOVES HS-CODE 401519	2820 CTN
2020080830087	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	GLOVES	1978 PKG
2020073128719	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	GLOVES	2120 CAS
2020072922327	Singapore,Singapore -> Tacoma, Washington	LATEX GLOVES HS-CODE 401519	2820 CTN
2020072519559	Singapore,Singapore -> Tacoma, Washington	LATEX GLOVES HS-CODE 401519	2820 CTN