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Kossan Latex Industries Sdn bhd

www.kossan.com.my

✓ Record-verifiedregistrations found in 4 marketsEU SRN MY-MF-000022331

This company has registrations in European Union, United States, United Kingdom, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

31UDI-DI device records

Class I 13Class IIa 18

USUnited StatesFDA openFDA

5listed device types

Class I 5Class II 0Class III 0

plus 24 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class I 7Class IIa 3

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union31 raw hits, 0 excluded, 31 confirmed

United States24 registration records, 19 510(k), 0 PMA, 3 excluded

United Kingdom10 confirmed, 0 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: KOSSAN LATEX INDUSTRIES (M) SDN BHD · KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

Regulatory identity

EU manufacturer SRN: MY-MF-000022331
EU authorised representative: Advena Limited
UK responsible person: Advena Ltd
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

FDA 510(k) clearances by year

11989

21997

41998

21999

22000

12002

32006

12007

12011

12012

12013

FDA listed device types

Fentanyl And Other Opioid Protection Glove 1Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Latex Patient Examination Glove 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	09555256602009	iNtouch V Natural	Class I
EU	09555256609954	iNtouch Powder Free	Class IIa
EU	09555256609886	iNtouch Powder Free	Class IIa
EU	09555256608193	iNtouch Powder Free	Class IIa
UK	47172	Latex exam gloves – non sterile	Class I
UK	47172	Powder Free Latex Exam Gloves, Non-Sterile	Class I
UK	47178	iNtouch Sterile Powder Free Latex Surgical Gloves	Class IIa
US	K123749	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE	2013-03-01
US	K120066	POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL	2012-11-16
US	K111772	POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE	2011-10-20
CA	75473	NITRILE MEDICAL EXAMINATION GLOVES	Class II
CA	75474	LATEX MEDICAL EXAMINATION GLOVES	Class II

Kossan Latex Industries Sdn bhd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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