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Medical Glove Co., Ltd.

Thailand · Lam Thap

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Israel — 3 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

5listed device types

Class I 5Class II 0Class III 0

plus 7 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

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 States7 registration records, 9 510(k), 0 PMA, 133 excluded

Brazil0 confirmed, 16 excluded

Saudi Arabia2 confirmed, 41 excluded

Canada0 confirmed, 17 excluded

Manufacturer names merged into this page: TOP GLOVE MEDICAL (THAILAND) CO., LTD. · US MEDICAL GLOVE COMPANY · TOP GLOVE MEDICAL (THAILAND) CO.,LTD. · Medical Glove Co., Ltd

FDA 510(k) clearances by year

11989

11993 · K930514

22002 · K022016

12021 · K212551

22022 · K213934

22023 · K222129

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
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	K223748	Nitrile Exam Gloves (Chemotherapy Drug Tested)	2023-01-13
US	K213934	Pro Guard Nitrile Powder Free Examination Glove	2022-08-06
SA	ME0000017106SFDAA00001	Latex Examination Gloves Powder Free	—
SA	ME0000004335SFDAA00002	MG Micro-care Latex Powder Free Examination Gloves	—

Medical Glove Co., Ltd.

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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