Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004105221

FEI Number

3004105221

Entity Name

HUBEI HUANFU PLASTIC PRODUCTS CO., LTD

City/State/Country

HANCHUAN CITY Hubei, CN

Establishment Address

No. 188 WANFU STREET, CHENHU TOWN, HANCHUAN CITY Hubei 431608, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hubei Huanfu Plastic Products Co., Ltd. (Owner Number: 9057645)

Owner / Operator Contact Address

No. 188 Wanfu Street, Chenhu Town, Hanchuan, CN-HB 431608, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SURGICAL#GENERAL AND PLASTIC SURGE, RY, CAP Coverall Isolation Gown; gown; lab coat; lab jacket; Disposable Apron; Disposable PANT; Disposable COAT; scrub suit Surgical Face Mask blanket Disposable Bedding Expectant Father Kits CONDUCTIVE#GENERAL AND PLASTIC SUR, SHOE COVER, GERY Burn Sheet Face Mask Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2003-07-28
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2009-11-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-12-24
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-05-10
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2009-09-24
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2003-07-28
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2012-05-10
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2015-09-22
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-01
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-28

Official Correspondent

Emily Chen

US Agent Details

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

Related Public Records

Same Entity

Hubei Huanfu Plastic Products 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004105221. Last updated year: 2026. Please use registration number 3004105221 when referencing this establishment in official correspondence.