HomeChinaFitone Latex Products Co., Ltd. Guangdong

Fitone Latex Products Co., Ltd. Guangdong

China · Zhanjiang
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class I 7Class II 3
11 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 1 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.

United States0 registration records, 4 510(k), 0 PMA
Brazil10 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: FITONE LATEX PRODUCTS CO., LTD. GUANGDONG · FITONE LATEX PRODUCTS CO., LTD · Fitone Latex Products Co., Ltd. Guangdong
Same-named companies — This database also contains companies with near-identical names: FITONE LATEX PRODUCTS CO., LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Zhanjiang

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

12021 · K211927
22022 · K221747
12023 · K231446

Registration details (sample)

MarketIdentifierNameClass / date
USK231446Single-Use Latex Sterile Surgical Gloves (SG100)2023-09-22
USK221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs2022-12-01
USK222693Single-use medical latex examination gloves (LG100)2022-09-24
BR80660079063LUVA DE LÁTEX CIRÚRGICA SEM PÓ ZELARAClass II
BR80660070069Protetor de Sonda ZelaraClass I
BR80722800024Protetor de Sonda para Ultrassom MedPexClass I
SAME0000020086SFDAA00001Disposable Medical latex Examination Glove

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