Home›China›Tg Medical (China) Incorporation

Tg Medical (China) Incorporation

China · Zhangjiagang Jiangsu Province

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, 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

pendingnot queried

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

23registered devices

Class I 13Class II 10

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

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.

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

Brazil23 confirmed, 4 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 · TG Medical Sdn. Bhd. · 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	81692310001	LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO EM LÁTEX - COM PÓ - LUVIX	Class I
BR	81569610001	LUVA CIRÚRGICA ESTÉRIL LÁTEX BR NEW HAND TEXTURIZADA	Class II
BR	81569610002	luva de procedimento não estéril látex br	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 (China) Incorporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies