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SRI TRANG GLOVES THAILAND PLC

Thailand · Bangkok · www.sritranggroup.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN TH-MF-000010448

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 284Class IIa 16

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

5listed device types

Class I 5Class II 0Class III 0

plus 24 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

17registered device records

Class I 16Class IIa 1

BRBrazilANVISA

50registered devices

Class I 50

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

SASaudi ArabiaSFDA

26registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

24 including historic records

TWTaiwanTFDA

16valid device licences

Class I 16

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

28active ARTG entries

Class I 28

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

19registrations

RURussiaRoszdravnadzor

7active registrations

Class 1 7

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 Union338 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

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

United Kingdom17 confirmed, 0 excluded

Brazil50 confirmed, 0 excluded

Saudi Arabia26 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED. · SRI TRANG GLOVES (THAILAND) PUBLIC COMPANY LIMITED · SRI TRANG USA, INC. · SRI TRANG GLOVES (THAILAND) CO., LTD · Sri Trang Gloves (Thailand) Public Company Limited · Sri Trang Gloves Co Ltd

Regulatory identity

EU manufacturer SRN: TH-MF-000010448
EU authorised representative: MDSS GmbH
UK responsible person: MDSS-UK RP LIMITED

FDA 510(k) clearances by year

22019

22020 · K200539

32022 · K221165

32024 · K240266

FDA listed device types

Fentanyl 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
EU	08859130662969	Prosenso Nitrile Gloves	Class I
EU	08859130662655	VITASKIN LATEX POWDER-FREE SURGICAL GLOVES	Class IIa
EU	08859130662648	VITASKIN LATEX POWDER-FREE SURGICAL GLOVES	Class IIa
EU	08859130662631	VITASKIN LATEX POWDER-FREE SURGICAL GLOVES	Class IIa
UK	47172	Latex Examination Gloves, Powder Free, Polymer Coated, Sterile	Class I
UK	47172	AURON	Class I
UK	47172	Peha-Soft® Latex Comfort L	Class I
US	K240266	Latex Examination Glove Powder Free (Ocean Blue and Natural White)	2024-09-09
US	K240930	Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue	2024-07-02
US	K232614	Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)	2024-05-13
BR	10330660376	Luva de Látex para Procedimentos não Cirúrgicos Powder Free Descarpack	Class I
BR	81628880081	Luva látex para procedimento não cirúrgico com pó	Class I
BR	81628880082	Luva látex para procedimento não cirúrgico sem pó	Class I
SA	ME0000002190SFDAA00003	KABAYAN Examination Gloves	—
SA	ME0000002190SFDAA00009	Nitrile Examination gloves	—
CA	18596	SYNTHETIC EXAM GLOVES	Class II
CA	23570	SEMPERCARE SYNTHETIC VINYL EXAMINATION GLOVES	Class II
CA	69525	POLYMED TLC POWDER-FREE LATEX EXAMINATION GLOVES	Class II