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LATEXX MANUFACTURING SDN. BHD.

Malaysia · Perak

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 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

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 6Class II 0Class III 0

plus 24 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

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

0active device licences

4 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 1 3Class 2a 1

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.

United States24 registration records, 10 510(k), 0 PMA, 2 excluded

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: LATEXX MANUFACTURING SDN. BHD. · LATEXX MANUFACTURING SDN BHD

FDA 510(k) clearances by year

72002 · K022346

12004 · K034052

12010 · K101645

12012 · K102189

FDA listed device types

Surgeon'S Gloves 1Fentanyl 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
US	K102189	POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM	2012-03-14
US	K101645	NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF	2010-08-26
US	K034052	BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES	2004-03-15
BR	80495510003	TOP QUALITY - LUVAS DE LÁTEX PARA PROCEDIMENTO NÃO CIRÚRGICO, COM PÓ -	Class I
BR	80273450011	Luva para procedimento DE LATEX - marca GLOMED	Class I
BR	80044540041	LUVA DE PROCEDIMENTO DE LÁTEX LAGROTTA AZZURRA	Class I

LATEXX MANUFACTURING SDN. BHD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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