HomeMalaysiaM.R. Rubber Industries Sdn. Bhd.

M.R. Rubber Industries Sdn. Bhd.

Malaysia · Setapak Kuala Lump
✓ 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 4Class II 1Class III 0
plus 36 registration records and 59 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 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 States36 registration records, 59 510(k), 0 PMA, 157 excluded
Brazil4 confirmed, 24 excluded
Saudi Arabia7 confirmed, 8 excluded
Canada0 confirmed, 12 excluded
Manufacturer names merged into this page: HL RUBBER INDUSTRIES SDN BHD · I QUALITY RUBBER INDUSTRIES SDN. BHD. · SAGAMI RUBBER INDUSTRIES CO., LTD. · COMFORT RUBBER GLOVES INDUSTRIES SDN BHD · KOSSAN RUBBER INDUSTRIES BHD · HL RUBBER INDUSTRIES SDN. BHD.

Company information

Country
Malaysia
City
Setapak Kuala Lump

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

191989
41990
11992
21994
21996
11998
71999
32000
22007
22010
12011
12013
22014
22017
12018
12019
22020
12022
22024
12025

FDA listed device types

Polymer Patient Examination Glove 1Medical Glove, Specialty 1Latex Patient Examination Glove 1Fentanyl And Other Opioid Protection Glove 1Condom 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein2025-04-29
USK240269Nitrile Powder Free Examination Gloves Biodegradable (Green)2024-10-25
USK241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential2024-08-06
BR80044540028LUVAS NITRÍLICAS PARA PROCEDIMENTOS NÃO CIRÚRGICOS SEM PÓ LAGROTTA AZZClass I
BR80306640013LUVA PARA PROCEDIMENTO GRANDESCClass I
BR10201230124LUVA DE LÁTEX PARA PROCEDIMENTO NÃO ESTÉRIL (COM PÓ)Class I
SAME0000013895SFDAA00001Heartmed Latex Gloves
SAME0000013895SFDAA00002WINMED Latex Examination Gloves

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