Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013528379

FEI Number

3013528379

Entity Name

HUBEI KANGCHENG NON-WOVEN CO., LTD

City/State/Country

XIANTAO Hebei, CN

Establishment Address

NO.8 WEST OF PENGCHANG ROAD, PENGCHANG TOWN, XIANTAO Hebei 433018, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HUBEI KANGCHENG NON-WOVEN CO., LTD (Owner Number: 10054456)

Owner / Operator Contact Address

NO.8 WEST OF PENGCHANG ROAD, PENGCHANG TOWN, XIANTAO, CN-HE 433018, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BEARD COVER;GLOVE;WASH GLOVES AND WIPES;SOAPED WASH GLOVES;APRONS;DENTAL BIBS CAPS,SHAMPOO CAPS BED SHEETS;UNDERPAD;EMERGENCY BLANKET; BED COVER;BLANKET;PILLOW;PILOW COVE ISOLATION GOWN;VISITOR KITS;LAB COAT WET WIPES SHOE COVER,BOOT COVER,SLEEVE COVERALL cleanser, denture, over the counter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2017-03-21
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2017-03-21
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2017-03-21
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2017-03-21
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2017-03-21
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2017-03-21
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2017-03-21
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2017-03-21

Official Correspondent

LUKE LUKE

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HUBEI KANGCHENG NON-WOVEN CO., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

Similar Registrations

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3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013528379. Last updated year: 2026. Please use registration number 3013528379 when referencing this establishment in official correspondence.