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Smart Glove Corporation Sdn. Bhd.

Malaysia · Klang

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Australia — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

32510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 32 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

14 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

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 States0 registration records, 32 510(k), 0 PMA, 140 excluded

Brazil0 confirmed, 16 excluded

Saudi Arabia1 confirmed, 42 excluded

Canada4 confirmed, 15 excluded

Manufacturer names merged into this page: SMART GLOVE CORPORATION SDN. BHD. · PT SMART GLOVE INDONESIA · Smart Glove Corporation Sdn Bhd

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213373	Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate	2022-03-10
US	K183280	PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs	2019-07-26
US	K181047	Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs	2019-01-09
SA	ME0000019093SFDAA00001	Gen-X	—
CA	100622	SYNTHETIC LATEX EXAMINATION GLOVE	Class II
CA	105119	NATURAL RUBBER LATEX EXAMINATION GLOVE	Class II
CA	105184	NATURAL RUBBER LATEX EXAMINATION GLOVES	Class II

Smart Glove Corporation Sdn. Bhd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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