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Top Glove Sdn. Bhd.

Malaysia · Shah Alam Selangor · www.topglove.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN MY-MF-000009690Unified social credit code 91320582737847556X

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥270, the first 300 verified individually. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

≥270UDI-DI device records

Class I 263Class IIa 7

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

USUnited StatesFDA openFDA

6listed device types

Class I 6Class II 0Class III 0

plus 11 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class I 9Class IIa 1

BRBrazilANVISA

31registered devices

Class I 31

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

SASaudi ArabiaSFDA

83registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

4 including historic records

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

31active ARTG entries

Class I 28Class Is (sterile) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

20active registrations

Class 1 18Class 2a 2

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 Union3,907 raw hits, 30 excluded, 270 confirmed. Large result set — only the first 300 verified

United States11 registration records, 24 510(k), 0 PMA, 135 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom10 confirmed, 12 excluded

Brazil31 confirmed, 12 excluded

Saudi Arabia83 confirmed, 31 excluded

Canada3 confirmed, 16 excluded

Manufacturer names merged into this page: TOP GLOVE SDN. BHD. · TOP GLOVE MEDICAL (THAILAND) CO., LTD. · TOP GLOVE SDN BHD (FACTORY 2) · TOP GLOVE SDN BHD · TOP GLOVE VIETNAM COMPANY LIMITED · TOP GLOVE SSN. BHD. (FACTORY 24)

Regulatory identity

EU manufacturer SRN: MY-MF-000009690
EU authorised representative: Ulma International GmbH
UK responsible person: Obelis UK Ltd
Unified social credit code: 91320582737847556X
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2002-05-08
Registered capital: CNY 85,000,000
Paid-in capital: CNY 85,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Rubber and plastic products
Last approval date: 2025-08-13
Recognitions: Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

11991

11994

21998

51999

12000

32002

32003

12012

22017

12018

22020

12022

12023

FDA listed device types

Surgeon'S Gloves 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
EU	09551004354756	Lab Prime	Class I
EU	09551004354749	Lab Prime	Class I
EU	09551004354732	Lab Prime	Class I
EU	09551025331866	GRINDOR	Class I
UK	47509	Non Sterile Cleanroom Glove	Class I
UK	47178	Powder Free Latex Surgical Glove, Sterile	Class IIa
UK	56286	Non Sterile Cleanroom Glove	Class I
US	K222129	Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim	2023-02-10
US	K212011	Vinyl Powder Free Examination Glove	2022-02-14
US	K192111	Biodegradable Nitrile Examination Powder Free Glove, Green	2020-09-03
BR	80630310002	luva para procedimento de nitrilo não estéril	Class I
BR	80273450044	Luvas para procedimento Nitrílica Marca GLOMED NITRIL	Class I
BR	80499940024	Luvas de Látex sem pó Top Glove/Supermedy	Class I
SA	ME0000000225SFDAA00002	Basmat	—
SA	ME0000009743SFDAA00005	Nitrile Examination Gloves	—
CA	14145	TOP GLOVE NITRILE EXAMINATION GLOVES BLUE (POWDERED & POWDER FREE)	Class II
CA	14146	TOP GLOVE VINYL EXAMINATION GLOVES (POWDERED AND POWDER FREE)	Class II
CA	14148	TOP GLOVE LATEX SURGICAL STERILIZED (POWDERED AND POWDER FREE)	Class II