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Wuhan Zonsen Medical Products Co., Ltd: FDA-registered device maker in Wuhan Hubei, China, 5 510(k) clearances

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

Wuhan Zonsen Medical Products Co., Ltd is registered with the FDA (registration 3015140351) in Wuhan Hubei, China. It lists 24 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 25, 2023. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3015140351
Address: No. 8 Jinchao Road, Zhucheng Street, Xinzhou District, Wuhan Hubei, China, 431000
Owner or operator: Wuhan Zonsen Medical Products Co., Ltd (10059207)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: December 11, 2018
Registered through: 2027
Brand names listed: ACCESSORY, SURGICAL APPAREL, ALCOHOL PREP PAD; BZK PAD; CLEANSING WIPE; NONWOVEN PAD; OB TOWOLETTE, COVER, SHOE, OPERATING-ROOM, CSR Wrap, Cotton roll, Dental cotton, Disposable Medical Bedding, Drape, Surgical, Exempt, Elastic adhesive bandage, Cohesive bandage and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Component, Cast	LGF	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	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	Exporter to the US, Manufacturer	accessdata.fda.gov
First Aid Kit With Drug	LRR	N	Exporter to the US, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Manufacturer	accessdata.fda.gov
Gown, Isolation, Surgical	FYC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Mask, Scavenging	KHA	1	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Suit, Surgical	FXO	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	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
August 25, 2023	K223600	Sterilization Wrap	FRG	Substantially Equivalent	Wuhan Zonsen Medical Products Co., Ltd.	accessdata.fda.gov
December 16, 2022	K213601	Surgical Mask	FXX	Substantially Equivalent	Wuhan Zonsen Medical Products Co., Ltd.	accessdata.fda.gov
February 18, 2022	K213688	Nitrile Examination Gloves (Model: ZMG1351)	LZA	Substantially Equivalent	Wuhan Zonsen Medical Products Co., Ltd.	accessdata.fda.gov
January 20, 2022	K212357	Surgical isolation gown	FYC	Substantially Equivalent	Wuhan Zonsen Medical Products Co., Ltd.	accessdata.fda.gov
December 15, 2021	K212861	Surgical Gown, Reinforced Surgical Gown	FYA	Substantially Equivalent	Wuhan Zonsen Medical Products Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 25, 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.