Data / Medical devices / China / Jiangsu Guangda Medical Material Group Co., Ltd.

Jiangsu Guangda Medical Material Group Co., Ltd.: FDA-registered device maker in Haian Jiangsu, China, 3 510(k) clearances

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

Jiangsu Guangda Medical Material Group Co., Ltd. is registered with the FDA (registration 3006847952) in Haian Jiangsu, China. It lists 32 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 15, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006847952
Address: 18 Baochang Road North, Haian Jiangsu, China, 226631
Owner or operator: Jiangsu Guangda Medical Material Group Co., Ltd. (10023676)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 7, 2007
Registered through: 2026
Brand names listed: BANDAGE, ELASTIC, Cotton Ball; Cotton Roll, Cotton Tipped Applicators, Sterile, Cover, Coverall, DRAPE, SURGICAL, Device, Occlusion, Umbilical, Drape, Surgical, Exempt and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Applicator, Ent	KCJ	1	Manufacturer	accessdata.fda.gov
Bag, Ice	KYR	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Counter, Sponge, Surgical	LWH	1	Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Depressor, Tongue, Non-Surgical	FMA	1	Manufacturer	accessdata.fda.gov
Device, Occlusion, Umbilical	FOD	1	Repackager or relabeler	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Dissector, Tonsil	KBM	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dress, Surgical	FYE	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	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	Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer, Specification developer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pad, Eye	HMP	1	Manufacturer	accessdata.fda.gov
Parenteral Administration Kit	POR	2	Repackager or relabeler	accessdata.fda.gov
Sheet, Burn	FPY	1	Manufacturer	accessdata.fda.gov
Stabilizer, Heart	MWS	1	Contract manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	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
April 15, 2021	K201718	GD Disposable Medical Face Mask	FXX	Substantially Equivalent	Jiangsu Guangda Medical Material Group Co., Ltd.	accessdata.fda.gov
December 12, 2012	K121152	SURGICAL GOWN, SMS	FYA	Substantially Equivalent	Jiangsu Guangda Medical Material, Co., Ltd.	accessdata.fda.gov
August 17, 2000	K001858	OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE	KKX	Substantially Equivalent	China Nantong Guangda Textile Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 15, 2021. 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.