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MAXTER GLOVE MANUFACTURING SDN. BHD

Malaysia · Klang Selangor

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 7 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

4listed device types

Class I 4Class II 0Class III 0

plus 8 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

SASaudi ArabiaSFDA

24registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

Class I 13

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

4active registrations

Class 1 4

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 States8 registration records, 9 510(k), 0 PMA, 3 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia24 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MAXTER GLOVE MANUFACTURING SDN BHD · MAXTER GLOVE MANUFACTURING SDN. BHD · Maxter Glove Manufacturing Sdn Bhd · MAXTER GLOVE MANUFACTURING SDN BHD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172864	Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs	2018-05-02
US	K151390	Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs	2016-05-02
US	K113100	POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS	2012-02-06
BR	80105840002	Supermax premium quality com pó	Class I
BR	80105840003	LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO	Class I
BR	80105840006	LUVA DE NITRILO PARA PROCEDIMENTOS SUPERMAX	Class I
SA	ME0000001039SFDAA00008	Non Sterile Powder Free Latex Examination Gloves	—
SA	ME0000009255SFDAA00001	MAXTER	—

MAXTER GLOVE 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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