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Rizhao Sanqi Medical & Health Articles Co., Ltd: FDA-registered device maker in Rizhao Shandong, China, 2 510(k) clearances

Name: Rizhao Sanqi Medical & Health Articles Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Rizhao Sanqi Medical & Health Articles Co., Ltd is registered with the FDA (registration 3010374972) in Rizhao Shandong, China. It lists 18 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 24, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010374972
Address: Heshan Industrial area, Rizhao Shandong, China, 276800
Owner or operator: RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD (10044543)
Roles: Exporter to the US, Manufacturer
First device listed: June 25, 2013
Registered through: 2026
Brand names listed: 3Q FFP 2 NR, 3Q KN95, 3Q KN95 9505, Absorbent Core Paper; Absorbent Pad; Absorbent Paper;, Absorbent sheet; Biohazard Specimen Bag;, Absorber, Saliva, Paper, Accessory, Surgical Apparel, check pants,Sleeve cover, Medical Face Shield with or without Glass, Bandage, Liquid, Skin Protectant and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Manufacturer	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Apron, Protective	IWO	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bandage, Liquid, Skin Protectant	NEC	1	Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	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
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Non-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)	QKU	N	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	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
March 24, 2022	K202903	Surgical Face Mask	FXX	Substantially Equivalent	Rizhao Sanqi Medical & Health Articles Co., Ltd.	accessdata.fda.gov
September 10, 2010	K093901	SURGICAL FACE MASK	FXX	Substantially Equivalent	Epard Protective Products, Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 24, 2022. 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.