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Lianyungang Anson Non-woven Product Co., Ltd.: FDA-registered device maker in Lianyungang Jiangsu, China, 1 510(k) clearance

Name: Lianyungang Anson Non-woven Product Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lianyungang Anson Non-woven Product Co., Ltd. is registered with the FDA (registration 3008959420) in Lianyungang Jiangsu, China. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 8, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3008959420
Address: No. 9 Hongkong Rd. Ganyu Economic Development Zone, Lianyungang Jiangsu, China, 222000
Owner or operator: Lianyungang Anson Non Woven Product Co., Ltd. (10035774)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: March 23, 2011
Registered through: 2026
Brand names listed: SurgiPlus Surgical Gown

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Contract manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Contract manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Contract manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Contract manufacturer	accessdata.fda.gov
Gown, Isolation, Surgical	FYC	2	Contract manufacturer	accessdata.fda.gov
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection	QPC	2	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Contract manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Contract manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Contract manufacturer, Repackager or relabeler	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
August 8, 2023	K222128	Protective Gown AAMI Level 4	QPC	Substantially Equivalent	Kenpax International Limited	accessdata.fda.gov

Compare with other makers

Updated August 8, 2023. 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.