HomeChinaSHANDONG XINGYU GLOVES CO.,LTD

SHANDONG XINGYU GLOVES CO.,LTD

China · 潍坊
✓ Record-verifiedregistrations found in 5 marketsUnified social credit code 9137078577418160X7

This company holds 4 NMPA certificates in China and has registrations in United States, Brazil, Canada, Australia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class I 1Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
4listed device types
Class I 4Class II 0Class III 0
plus 3 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class I 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
1active device licences
Class II 1
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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.

European Union1,463 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States3 registration records, 4 510(k), 0 PMA, 2 excluded
China4 certificates (Class III 0 / II 3 / I 1), as of 2026-09-04
United Kingdom0 confirmed, 2 excluded
Brazil2 confirmed, 1 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: SHANDONG XINGYU GLOVES CO., LTD

Regulatory identity

Unified social credit code
9137078577418160X7
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
2,572
Annual revenue
over RMB 500M
Product categories
医用耗材注输、护理和防护器械

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.

Business registration

Registration status
Active
Incorporated
2005-04-14
Registered capital
CNY 298,000,000
Paid-in capital
CNY 288,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Textiles
Last approval date
2025-06-10
Recognitions
Gazelle enterpriseRecognised enterprise technology centreTechnology Innovation Demonstration EnterpriseHidden champion

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

22017 · K171615
12022 · K221272
12024 · K233990

FDA listed device types

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Fentanyl And Other Opioid Protection Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20232140546医用防护口罩Class II
CN鲁械注准20232140049医用外科口罩Class II
CN鲁械注准20202141306一次性使用医用口罩Class II
CN鲁潍械备20160042号一次性丁腈检查手套Class I
USK233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)2024-04-01
USK221272Medical Face Mask2022-06-28
USK171615Xingyu Nitrile Powder Free Patient Examination Gloves, White color2017-07-31
BR81669050007LUVA SUPER NITRILICA LIGHTClass I
BR81669050001LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO EM NITRILO - SUPER SAFETY BIOClass I
CA107294NITRILE DISPOSABLE EXAMINATION GLOVESClass II

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