HomeIndonesiaUniversal Gloves Corp.

Universal Gloves Corp.

Indonesia · Medan Sumatera Utara
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel — 5 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
2listed device types
Class I 2Class II 0Class III 0
plus 3 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
17registered devices
Class I 15Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
6valid device licences
Class I 6
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States3 registration records, 7 510(k), 0 PMA, 42 excluded
Brazil17 confirmed, 3 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: PT. UNIVERSAL GLOVES
Same-named companies — This database also contains companies with near-identical names: Universal Gloves Private , Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Indonesia
City
Medan Sumatera Utara

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

21989 · K893015
11990 · K900092
11998 · K980093
22021 · K203074
12022 · K211360

FDA listed device types

Polymer Patient Examination Glove 1Latex Patient Examination Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK211360Disposable Nitrile Powder Free Examination Gloves (Non-sterile)2022-01-15
USK203074Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)2021-11-19
USK201576Disposable Latex Powder Free Examination Gloves (Non-sterile)2021-05-19
BR10330660377Luva de Látex para Procedimentos não Cirúrgicos Powder Free DescarpackClass I
BR81229609011LUVA PARA PROCEDIMENTO CIRÚRGICO EM LÁTEX-SEM PÓ-SOFT+AID - EMBRASTClass II
BR80495510234MEDIX BRASIL LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE NITRILO SEM PÓClass I

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