Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009538921

FEI Number

3009538921

Entity Name

KOSSAN INTERNATIONAL SDN BHD

City/State/Country

Shah Alam Selangor, MY

Establishment Address

KOSSAN Tower, No. 6D, Persiaran Setia Dagang, Setia Alam, Seksyen U13,, Shah Alam Selangor 40170, MY

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Kossan International Sdn Bhd (Owner Number: 10039751)

Owner / Operator Contact Address

KOSSAN Tower No. 6D, Persiaran Setia Dagang, Setia Alam, Seksyen U13, Shah Alam, MY-10 40170, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093500

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
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-08-26
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-08-26
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-08-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2015-05-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2019-10-10
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2015-01-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-03-17
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-02-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-02-05
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-02-05
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2026-02-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-08-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-08-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-08-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-08-09
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2012-02-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-06-10
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2019-06-10
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2019-06-10
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-08-12
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2014-10-13
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2016-08-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-08-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2015-01-12
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2017-07-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-07-17
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2019-02-12
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-09-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-11-02
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2018-01-04
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-05-09
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-05-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-05-09
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-05-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-03-17
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-03-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2014-09-23
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-11-25
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2014-10-13
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2016-02-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2016-02-29
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2018-02-06
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2023-09-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-06-17
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-06-17
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2015-05-05

Official Correspondent

Lim Siau Tian

US Agent Details

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

Related Public Records

Same Entity

Kossan International 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 3009538921. Last updated year: 2026. Please use registration number 3009538921 when referencing this establishment in official correspondence.