Hubei Huanfu Plastic Products Co., Ltd.

Manufacturer and brand owner in Hanchuan, Hubei, China. 12 device types, 5 products catalogued, 1 clearance.

Registry build 21.09.26

Hubei Huanfu Plastic Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Sheet, Burn, Cap, Surgical and 10 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2003.

12device types registered with the FDA
5products catalogued under its own name
1510(k) clearance

Registration

FDA registration record for Hubei Huanfu Plastic Products Co., Ltd.
Registered name HUBEI HUANFU PLASTIC PRODUCTS CO., LTD
Status Registered
Registration expires 2026
Registration number 3004105221
FEI number 3004105221
DUNS 530032259
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Hubei Huanfu Plastic Products Co., Ltd.
Chinese legal name 湖北环福塑料制品有限公司
Source Qichacha company register

Location

Address of Hubei Huanfu Plastic Products Co., Ltd.
City Hanchuan
Province Hubei
Address No. 188 WANFU STREET, CHENHU TOWN
Postal code 431608
Country China

What It Makes

Device types Hubei Huanfu Plastic Products Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 Face Mask 2020 439
Bedding, Disposable, Medical Class 1 blanket, Disposable Bedding 2012 308
Cap, Surgical Class 1 Surgical#general AND Plastic Surge, RY, CAP 2003 178
Cover, Shoe, Operating-Room Class 1 2015 176
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Class N Face Mask 2020 182
Gown, Examination Class 1 Examination#general Hospital, Gown 2003 109
Mask, Surgical Class 2 Surgical Face Mask 2021 125
Non-Surgical Gown Class 1 Coverall, Isolation Gown; gown; lab coat; lab jacket; Disposable Apron; Disposable PANT; Disposable COAT; scrub suit 2009 318
Sheet, Burn Class 1 Burn Sheet 2012 20
Shield, Protective, Personnel Class 1 Personnel#radiology 2003 78
Shoe And Shoe Cover, Conductive Class 1 Conductive#general AND Plastic SUR, Shoe Cover, Gery 2003 32
Suit, Surgical Class 1 Expectant Father Kits 2009 74

Own-Brand Listings

Devices catalogued by Hubei Huanfu Plastic Products Co., Ltd.
Product Code Catalogue numbers
Huanfu OEA 2
Huanfu FXP 2
Huanfu KME 2
Huanfu FYF 1
Huanfu FXO 1

Clearances

510(k) clearances naming Hubei Huanfu Plastic Products Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K212575 2021-11-14 FXX Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Hubei Huanfu Plastic Products Co., Ltd.
Founded 1994
Main products Spunbond nonwoven, CPE film, Medical caps, Surgical masks, Gowns, Protective coveralls
Certifications ISO9001:2000, ISO13485:2003, CE, NMPA (5 certificates)
Export markets EU, US, Brazil, Taiwan, Australia

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer