Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005632797

FEI Number

3005632797

Entity Name

KOSSAN LATEX INDUSTRIES (M) SDN BHD

City/State/Country

KLANG Selangor, MY

Establishment Address

LOT 6129,JALAN HAJI ABDUL MANAN, Batu 5 1/4, JALAN MERU, KLANG Selangor 41050, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (Owner Number: 8040735)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-09-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-09-12
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-03-31
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-03-31
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2008-01-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2011-02-08
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2012-05-28
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-10-30
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2009-02-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2011-10-24
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-10-23
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-07-24
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2012-03-27
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-06-18
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-06-18
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2009-02-05
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2013-06-14
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2022-01-23
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-01-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-01-23
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-06-17
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-06-17
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-06-17
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-06-17
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-07-17
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-07-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-17
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2012-07-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2011-09-21

Official Correspondent

LIM KWAN HWA

US Agent Details

Avani Patel Business: Parexel International Email: Avani.Patel@parexel.com Phone: (978) 4358575

Related Public Records

Same Entity

KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21
K101595	Better Care Plastic Technology Cp., Ltd.	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE	2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005632797. Last updated year: 2026. Please use registration number 3005632797 when referencing this establishment in official correspondence.