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Shandong Kangli Medical Equipment Technology Co., Ltd.: FDA-registered device maker in Zaozhuang Shandong, China, 1 510(k) clearance

Name: Shandong Kangli Medical Equipment Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shandong Kangli Medical Equipment Technology Co., Ltd. is registered with the FDA (registration 3014666579) in Zaozhuang Shandong, China. It lists 23 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 22, 2020. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3014666579
Address: Huiquan East Road, Shizhong District, Zaozhuang City, Shangdong Province, China, Zaozhuang Shandong, China, 277117
Owner or operator: Shandong Kangli Medical Equipment Technology Co., Ltd. (10058066)
Roles: Manufacturer
First device listed: July 3, 2018
Registered through: 2026
Brand names listed: Adhesive Mouldable Ring, Adhesive Strips, Barrier Cream, Bed Cover, Bed Sheets, Breast Drape, Cesarean section Drape, Colostomy Bag and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Bag, Stomal	GDS	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Closure, Wound, Adhesive	MGO	1	Manufacturer	accessdata.fda.gov
Cover, Mattress (Medical Purposes)	FMW	1	Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Pad, Kelly	FNW	2	Manufacturer	accessdata.fda.gov
Pouch, Colostomy	EZQ	1	Manufacturer	accessdata.fda.gov
Protector, Ostomy	EXE	1	Manufacturer	accessdata.fda.gov
Sheet, Burn	FPY	1	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
May 22, 2020	K192560	Surgical Gown	FYA	Substantially Equivalent	Shandong Kangli Medical Equipment Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 22, 2020. 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.