Xingyu Medical Tech Co., Ltd.

Manufacturer and brand owner in Weifang, Shandong, China. 4 device types, 1 product catalogued, 4 clearances.

Registry build 21.09.26

Xingyu Medical Tech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Medical Glove, Specialty, Polymer Patient Examination Glove and 2 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2021.

4device types registered with the FDA
1product
4510(k) clearances

Registration

FDA registration record for Xingyu Medical Tech Co., Ltd.
Registered name XINGYU MEDICAL TECH CO.,LTD
Status Registered
Registration expires 2026
Registration number 3018779144
FEI number 3018779144
DUNS 715315228
Establishment type Contract manufacturer, Manufacturer, Exporter

Location

Address of Xingyu Medical Tech Co., Ltd.
City Weifang
Province Shandong
Address No.2189 Yaoqian Road, Gaomi Economic Development Zone,
Postal code 261500
Country China

What It Makes

Device types Xingyu Medical Tech Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Fentanyl And Other Opioid Protection Glove Class 1 Nitrile Disposable Examination Gloves, Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl 2024 29
Medical Glove, Specialty Class 1 Nitrile Disposable Examination Gloves, Nitrile Disposable Examination Gloves (Tested For Use With Chemotherapy Drugs), Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl 2022 48
Medical Gloves With Chemotherapy Labeling Claims – Test For Use With Chemotherapy Drugs Class 1 Nitrile Disposable Examination Gloves, Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl 2024 32
Polymer Patient Examination Glove Class 1 Nitrile Disposable Examination Gloves, Xingyu Powder Free Nitrile Patient Examination Gloves, Blue Color, Nitrile Disposable Examination Gloves (Tested For Use With Chemotherapy Drugs), Nitrile Disposable Examination Gloves-510K, Xingyu Nitrile Powder Free Patient Examination Gloves, White Color, Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl 2021 83

Own-Brand Listings

Devices catalogued by Xingyu Medical Tech Co., Ltd.
Product Code Catalogue numbers
Xingyu Medical LZA 1

Clearances

510(k) clearances naming Xingyu Medical Tech Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K240629 2024-05-28 LZA Traditional This company
K221273 2022-06-28 FXX Traditional This company
K212735 2022-01-11 LZA Traditional This company
K212578 2021-12-02 LZA Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Xingyu Medical Tech Co., Ltd.
Founded 2015
Factory area 306,000+ ㎡
Main products Disposable nitrile gloves, Disposable latex gloves, Medical grade gloves, Food grade gloves, Industrial grade gloves
Certifications ISO 9001, ISO 13485, ISO 45001, ISO 14001, CE, UKCA, FDA, MDSAP, MDL
Export markets Over 100 countries

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer