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Foshan Nanhai Plus Medical Co Ltd: FDA-registered device maker in Foshan Guangdong, China, 6 510(k) clearances

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

Foshan Nanhai Plus Medical Co Ltd is registered with the FDA (registration 3006723155) in Foshan Guangdong, China. It lists 12 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 14, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006723155
Address: Shatou Jiujiang Town, Nanhai District, Foshan Guangdong, China, 528208
Owner or operator: FOSHAN NANHAI PLUS MEDICAL CO LTD (10040679)
Roles: Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: May 7, 2012
Registered through: 2027
Brand names listed: BAG, ICE, Cleaner, Ultrasonic, Medical Instrument, Disposable Face Mask, GOWN, SURGICAL, Mask, surgical, Plus Medical Cover Gown, Plus Medical Isolation Gown Level 3, STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES) and more

Devices it lists

Device	Product code	Class	Role	Source
Bag, Ice	KYR	1	Contract manufacturer	accessdata.fda.gov
Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy	QOZ	N	Manufacturer	accessdata.fda.gov
Cleaner, Ultrasonic, Medical Instrument	FLG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Gown, Isolation, Surgical	FYC	2	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Contract manufacturer, Foreign private label distributor, Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Contract manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Contract 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
November 14, 2022	K222480	Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)	FYA	Substantially Equivalent	Foshan Nanhai Plus Medical Co, Ltd.	accessdata.fda.gov
May 11, 2022	K213177	Plus Medical Cover Gown	FYA	Substantially Equivalent	Foshan Nanhai Plus Medical Co, Ltd.	accessdata.fda.gov
May 4, 2022	K211036	Plus Medical Chemotherapy Gown	FYA	Substantially Equivalent	Foshan Nanhai Plus Medical Co, Ltd.	accessdata.fda.gov
March 2, 2022	K212698	Plus Medical Isolation Gown Level 3	FYC	Substantially Equivalent	Foshan Nanhai Plus Medical Co, Ltd.	accessdata.fda.gov
January 26, 2022	K212610	Surgical Face Mask	FXX	Substantially Equivalent	Foshan Nanhai Plus Medical Co, Ltd.	accessdata.fda.gov
July 22, 2021	K210143	Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)	FYA	Substantially Equivalent	Foshan Nanhai Plus Medical Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 14, 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.