Data / Medical devices / China / Guangzhou Fuzelong Hygiene Material Co.,ltd.

Guangzhou Fuzelong Hygiene Material Co.,ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 2 510(k) clearances

Name: Guangzhou Fuzelong Hygiene Material Co.,ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Guangzhou Fuzelong Hygiene Material Co.,ltd. is registered with the FDA (registration 3008559312) in Guangzhou Guangdong, China. It lists 17 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 19, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3008559312
Address: #12, Guancun Road Jiangpu Street,Conghua, Guangzhou Guangdong, China, 510900
Owner or operator: GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD (10033567)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed: August 31, 2010
Registered through: 2026
Brand names listed: Disposable Medical Mask, Emesis Basin, IMPERTEC INDUSTRIES LTD Face Shield /Hood, Medline Surgical Face Mask and Medline Procedural Face Mask, PUYUAN, Protective Clothes (Protective Coveralls), Pu Yuan, Surgical Gown and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Bag, Ice	KYR	1	Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Drape, Adhesive, Aerosol	KGT	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Specification developer	accessdata.fda.gov
Gown, Examination	FME	1	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer	accessdata.fda.gov
Mask, Scavenging	KHA	1	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	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
May 19, 2023	K222545	Disposable Medical Mask	FXX	Substantially Equivalent	Guangzhou Fuzelong Hygiene Material Co., Ltd.	accessdata.fda.gov
January 26, 2023	K222403	Surgical Gown	FYA	Substantially Equivalent	Guangzhou Fuzelong Hygiene Material Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 19, 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.