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Weihai Hongyu Nonwoven Fabric Products Co.,Ltd: FDA-registered device maker in Weihai Shandong, China, 7 510(k) clearances

Name: Weihai Hongyu Nonwoven Fabric Products Co.,Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Weihai Hongyu Nonwoven Fabric Products Co.,Ltd is registered with the FDA (registration 3008489813) in Weihai Shandong, China. It lists 37 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 12, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008489813
Address: No.19-8 Guotai Road; Huancui District, Weihai Shandong, China, 264205
Owner or operator: Weihai Hongyu Nonwoven Fabric Products Co., Ltd (10033229)
Roles: Contract manufacturer, Manufacturer
First device listed: July 22, 2010
Registered through: 2026
Brand names listed: 16P, 7.5% lodine 10% lodine, Adhesive, Basin, Bed Bag, Bedcover, Bedsheet, Bowl:Kidney Tray and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Blade, Scalpel	GES	1	Manufacturer	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Clamp, Umbilical	HFW	2	Manufacturer	accessdata.fda.gov
Container, Liquid Medication, Graduated	KYW	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
Device, Incontinence, Urosheath Type, Sterile	EXJ	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Manufacturer	accessdata.fda.gov
Dress, Surgical	FYE	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer	accessdata.fda.gov
Hemostat	HRQ	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer	accessdata.fda.gov
Iodine (Tincture)	IAL	1	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Manufacturer	accessdata.fda.gov
Pen, Marking, Surgical	HRP	1	Manufacturer	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Manufacturer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Manufacturer	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Skin Prep Tray	OJU	1	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Contract manufacturer, 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 12, 2022	K214088	Disposable Surgical Gown	FYA	Substantially Equivalent	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	accessdata.fda.gov
March 10, 2022	K220133	Sterilization Wraps	FRG	Substantially Equivalent	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	accessdata.fda.gov
December 14, 2021	K213029	Nitrile Examination Gloves (Powder free, Blue)	LZA	Substantially Equivalent	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	accessdata.fda.gov
December 3, 2021	K212807	Surgical Masks	FXX	Substantially Equivalent	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	accessdata.fda.gov
April 14, 2015	K141324	HONGYU DISPOSABLE SURGICAL DRAPES	KKX	Substantially Equivalent	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	accessdata.fda.gov
October 16, 2012	K120192	DISPOSABLE SURGICAL GOWNS	FYA	Substantially Equivalent	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.	accessdata.fda.gov
February 25, 1997	K964142	MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS	KKX	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov

Compare with other makers

Updated April 12, 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.