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Tg Medical Sdn. Bhd.

Malaysia · Klang

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, 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

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 7Class II 0Class III 0

plus 17 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

29registered devices

Class I 18Class II 11

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

SASaudi ArabiaSFDA

16registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

14 including historic records

TWTaiwanTFDA

15valid device licences

Class I 14Class II 1

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

11GMP quality-system certificates

Business type not stated 1Import 10

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 1Class 2a 5

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 States17 registration records, 11 510(k), 0 PMA, 3 excluded

Brazil29 confirmed, 2 excluded

Saudi Arabia16 confirmed, 2 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: TG MEDICAL SDN BHD · TG MEDICAL SDN. BHD. · TG MEDICAL SDN BHD. (LOT 5104) · TG MEDICAL SDN BHD FACTORY - 14 · TG Medical Sdn. Bhd. · TG Medical Sdn. Bhd

FDA 510(k) clearances by year

11994

11998

51999 · K993562

22006 · K052985

12012 · K113393

12017 · K171276

FDA listed device types

Surgeon'S Gloves 1Dam, Rubber 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	K171276	Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs	2017-08-21
US	K113393	POWDER FREE BLACK NITRILE EXAMINATION GLOVES	2012-09-11
US	K052985	POWDER FREE VINYL EXAMINATION GLOVE	2006-01-19
BR	80982230009	LUVA DE LÁTEX PARA PROCEDIMENTO NÃO CIRÚRGICO	Class I
BR	81788080030	Luvas para procedimentos não cirúrgicos Látex com pó ABL VI	Class I
BR	81981090021	LÁTEX PROCEDIMENTO	Class I
SA	ME0000007151SFDAA00002	Best Gloves	—
SA	ME0000005574SFDAA00011	Nitrile Examination Gloves	—
CA	85087	KEEP KLEEN VINYL EXAMINATION GLOVES	Class II
CA	85088	KEEP KLEEN NITRILE EXAMINATION GLOVES	Class II
CA	85090	KEEP KLEEN LATEX EXAMINATION GLOVES	Class II

Tg Medical 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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