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Henan Huibo Medical Co., Ltd: FDA-registered device maker in Nanyang City Henan, China, 1 510(k) clearance

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

Henan Huibo Medical Co., Ltd is registered with the FDA (registration 3012852163) in Nanyang City Henan, China. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 26, 2021. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3012852163
Address: Weishi Road Central, Nanyang New Energy Economic & Technological Devlopment Zone, Nanyang City Henan, China, 473000
Owner or operator: Henan Huibo Medical CO., LTD (10053214)
Roles: Contract manufacturer, Manufacturer
First device listed: November 10, 2016
Registered through: 2026
Brand names listed: AZALLY Medical Silicone Scar Gel-30g, Alchocol Wipes; Disinfecting Hand Gel; Hand Sanitizer; Hand Sanitizer Gel; Hand Sanitizing Wipes; Sanitizing Wipes, Alginate dressings, Aroamas Advanced Medical Silicone Scar Gel-30g,45g, Aroamas Silicone Scar Removal Sheets-3in*1.6 in,8 Reusable Sheets,3in*1.6 in, 4 Reusable Sheets, 5.9in*1.6 in,4 Reusable, Compression Bandage, Compression Garments, Disposable Nonwoven Isolation Gown; Disposable Nonwoven Protective Clothing and more

Devices it lists

Device	Product code	Class	Role	Source
Beads, Hydrophilic, For Wound Exudate Absorption	KOZ	1	Manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Dressing, Compression	MHW	1	Contract manufacturer, 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
Elastomer, Silicone, For Scar Management	MDA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	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
Joint, Ankle, External Brace	ITW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mask, Scavenging	KHA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Manufacturer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Silicone Hydrogel For Scar Management	PFP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	DWL	2	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
November 26, 2021	K202842	Medical surgical mask	FXX	Substantially Equivalent	Henan Huibo Medical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 26, 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.