Motex Healthcare (Anhui) Co., Ltd.

Manufacturer and brand owner in Guangde City, Xuancheng, Anhui, China. 4 device types, 2 products catalogued, 1 clearance.

Registry build 21.09.26

Motex Healthcare (Anhui) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Surgeon’S Gloves, Medical Glove, Specialty and 2 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.

4device types registered with the FDA
2products catalogued under its own name
1510(k) clearance

Registration

FDA registration record for Motex Healthcare (Anhui) Co., Ltd.
Registered name MOTEX HEALTHCARE (ANHUI) CO., LTD.
Status Registered
Registration expires 2026
Registration number 3014269027
FEI number 3014269027
DUNS 560080502
Establishment type Manufacturer, Exporter

Chinese Registration

Chinese company register details for Motex Healthcare (Anhui) Co., Ltd.
Chinese legal name 华新医材(安徽)有限公司
Source Baidu Baike

Location

Address of Motex Healthcare (Anhui) Co., Ltd.
City Guangde City, Xuancheng
Province Anhui
Address Xinhang Economic Development Zone
Postal code 242234
Country China

What It Makes

Device types Motex Healthcare (Anhui) Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Latex Patient Examination Glove Class 1 Latex Patient Examination Glove 2018 12
Medical Glove, Specialty Class 1 Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs 2022 48
Polymer Patient Examination Glove Class 1 Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs, Polymer Patient Examination Glove 2018 83
Surgeon’S Gloves Class 1 Surgeon’s Glove 2018 10

Own-Brand Listings

Devices catalogued by Motex Healthcare (Anhui) Co., Ltd.
Product Code Catalogue numbers
MocareHealth KGO 398
MocareHealth LZA 8

Clearances

1 clearance names Motex Healthcare (Anhui) Co., Ltd. as applicant. 8 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Motex Healthcare (Anhui) Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K220155 2022-05-23 LZA Traditional This company
K123126 2014-06-04 KGO Traditional Shanghai Motex Healthcare Co., Ltd.
K132802 2014-05-21 KGO Traditional Shanghai Motex Healthcare Co., Ltd.
K122557 2013-10-03 KGO Traditional Shanghai Motex Healthcare Co., Ltd.
K063757 2007-07-27 KGO Traditional Shanghai Motex Healthcare Co., Ltd.
K041276 2004-08-20 LZA Traditional Shanghai Motex Healthcare Co., Ltd.
K030207 2003-05-02 LZA Traditional Shanghai Motex Healthcare Co., Ltd.
K020837 2002-12-02 LYY Traditional Shanghai Motex Healthcare Co., Ltd.
K013261 2001-11-29 LZA Traditional Shanghai Motex Healthcare Co., Ltd.

From the Company

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

Information published by Motex Healthcare (Anhui) Co., Ltd.
Founded 2012
Factory area 58,000 m²
Main products Examination gloves (NR), Examination gloves (NBR), Latex household gloves, Rubber household gloves
Certifications ISO 9001, ISO 13485, FDA registration
Export markets Global

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