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Supermax Glove Manufacturing Sdn Bhd

Malaysia · Sungai Buloh Selangor · www.supermax.com.my

✓ Record-verifiedregistrations found in 10 marketsEU SRN MY-MF-000016722

This company has registrations in European Union, United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 10 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

155UDI-DI device records

Class I 136Class IIa 19

USUnited StatesFDA openFDA

3listed device types

Class I 3Class II 0Class III 0

plus 13 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

2registered devices

Class I 2

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

SASaudi ArabiaSFDA

10registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

18active ARTG entries

Class I 18

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 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.

European Union155 raw hits, 0 excluded, 155 confirmed

United States13 registration records, 6 510(k), 0 PMA, 6 excluded

United Kingdom0 confirmed, 1 excluded

Brazil2 confirmed, 1 excluded

Saudi Arabia10 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

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

Regulatory identity

EU manufacturer SRN: MY-MF-000016722
EU authorised representative: Obelis s.a.
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	09551025331866	GRINDOR	Class I
EU	09551025331873	GRINDOR	Class I
EU	09551025331880	GRINDOR	Class I
EU	09551025331897	GRINDOR	Class I
US	K024083	GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR	2003-01-10
US	K014230	STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)	2002-03-13
US	K013953	AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM	2002-02-26
BR	80105840003	LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO	Class I
BR	80105840006	LUVA DE NITRILO PARA PROCEDIMENTOS SUPERMAX	Class I
SA	ME0000008817SFDAA00001	Powder Free Nitrile Examination Gloves Superlife	—
SA	ME0000008817SFDAA00002	Powder Free Latex Examination Gloves Superlife	—

Supermax Glove Manufacturing 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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