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Great Glove (Xin Hua) Co. Ltd.

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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 5 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

3registered 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

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 States5 registration records, 1 510(k), 0 PMA, 10 excluded

Brazil1 confirmed, 4 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: HUA CHENG XIN PLASTIC MOLD CO. LTD. · WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD · Great Glove (Xin Hua) Co. Ltd.

FDA 510(k) clearances by year

12002 · K021095

FDA listed device types

Container, Specimen, Sterile 1Container, Specimen, Non-Sterile 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Cassettes, Tissue 1Filters, Cell Collection, Tissue Processing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K021095	HOLY DRAGON BRAND ACUPUNCTURE NEEDLES	2002-05-17
BR	80679170003	Biqueira Descartável para Tatuagem com Agulhas - Reilly Tattoo	Class II
SA	ME0000010081SFDAA00006	Touch Vinyl Examination Gloves Powder Free	—
SA	ME0000010081SFDAA00005	Top Glove Disposable Vinyl Examination Gloves Powder Free	—

Great Glove (Xin Hua) 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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