Data / Medical devices / China / Jiangsu Nanfang Medical Co., Ltd.

Jiangsu Nanfang Medical Co., Ltd.: FDA-registered device maker in CHANGZHOU Jiangsu, China, 2 510(k) clearances

Name: Jiangsu Nanfang Medical Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jiangsu Nanfang Medical Co., Ltd. is registered with the FDA (registration 9710583) in CHANGZHOU Jiangsu, China. It lists 14 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 19, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9710583
FEI number: 3003514271
Address: No.1 Guoxiang RD. Wujin Economic Development Zone, WUJIN, CHANGZHOU Jiangsu, China, 213149
Owner or operator: Jiangsu Nanfang Medical Co., Ltd. (9048403)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: November 9, 2001
Registered through: 2026
Brand names listed: ADHESIVE DRESSING, Acti-Tape, Adhesive Retainer, Adhesive bandages, Cloth/Silk tape, Disposable Medical Mask, Elastic Bandage, Face Mask and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
First Aid Kit With Drug	LRR	N	Manufacturer	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Manufacturer	accessdata.fda.gov
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	OPJ	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Manufacturer	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Manufacturer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Manufacturer	accessdata.fda.gov
Sling, Arm	ILI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 19, 2022	K212826	Disposable Medical Mask	FXX	Substantially Equivalent	Jiangsu Nanfang Medical Co., Ltd.	accessdata.fda.gov
April 29, 2021	K210944	Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)	LZA	Substantially Equivalent	Harbour Health, LLC	accessdata.fda.gov

Compare with other makers

Updated January 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.