Hubei Xinxin NON-Woven Co., Ltd.

Manufacturer and brand owner in Xiantao, Hubei, China. 10 device types, 2 products catalogued, 4 clearances.

Registry build 21.09.26

Hubei Xinxin NON-Woven Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Gown, Surgical and 8 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.

10device types registered with the FDA
2products catalogued under its own name
4510(k) clearances

Registration

FDA registration record for Hubei Xinxin NON-Woven Co., Ltd.
Registered name HUBEI XINXIN NON-WOVEN CO., LTD
Status Registered
Registration expires 2026
Registration number 3011547453
FEI number 3011547453
DUNS 544358965
Establishment type Contract manufacturer, Manufacturer

Chinese Registration

Chinese company register details for Hubei Xinxin NON-Woven Co., Ltd.
Chinese legal name 湖北新鑫无纺布有限公司
Source customs registration record

Location

Address of Hubei Xinxin NON-Woven Co., Ltd.
City Xiantao
Province Hubei
Address Taizihu Industrial Park, Pengchang Town
Postal code 433018
Country China

What It Makes

Device types Hubei Xinxin NON-Woven Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 2015 439
Bedding, Disposable, Medical Class 1 2015 308
Cap, Surgical Class 1 2015 178
Cover, Shoe, Operating-Room Class 1 2015 176
Drape, Surgical, Antimicrobial Class 2 2023 39
Gown, Isolation, Surgical Class 2 AAMI 3 isolation Gown 2024 21
Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection Class 2 2019 3
Gown, Surgical Class 2 2023 68
Mask, Surgical Class 2 2022 125
Non-Surgical Gown Class 1 2015 318

Own-Brand Listings

Devices catalogued by Hubei Xinxin NON-Woven Co., Ltd.
Product Code Catalogue numbers
Sterile Level 3 Surgical Gown FYA 1
Reinforced Sterile Level 4 Surgical Gown FYA 1

Clearances

4 clearances name Hubei Xinxin NON-Woven Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Hubei Xinxin NON-Woven Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K253003 2026-04-20 FYA Traditional This company
K214116 2022-10-11 FYC Traditional This company
K213832 2022-05-16 FYC Traditional This company
K212120 2022-01-28 FXX Traditional This company
K232849 2024-05-16 FYC Abbreviated Owens & Minor (O&M) Halyard, Inc.
K182830 2019-04-26 QPC Traditional Cardinal Health200, LLC
K093115 2010-03-19 FYA Traditional Kimberly-Clark Corporation
K842115 1984-06-11 KKX Traditional Kimberly-Clark Corporation

From the Company

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

Information published by Hubei Xinxin NON-Woven Co., Ltd.
Founded 2014
Factory area 300 acres
Main products SMMS non-woven fabric, Surgical garments, Protective clothing, Shoe covers, Beard covers
Certifications ISO9001, ISO13485, FDA
Export markets Europe, North America, Asia (20+ countries)

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
Hubei V-Medical Products Co., Ltd. 46
Xiantao S&J Protective Products Co., Ltd. 41
Xiantao Rayxin Medical Products Co., Ltd. 18
Xiantao Daoqi Plastic Co., Ltd. 16
Hubei Wanli Protective Products Co., Ltd. 15
Hubei Feiteng Protective Products Co., Ltd. 14
V&Q Manufacturing Corporation 14
Hubei Weikang Protective Products Co., Ltd. 12
Xiantao Topmed Nonwoven Protective Products Co., Ltd. 11
Xiantao Zhongyi Safety & Protection Products Co., Ltd. 10
Hubei Kangcheng NON-Woven Co., Ltd. 10
Xiantao TSW Protective Products Co., Ltd. 10
Xiantao Sanda Industrial Co., Ltd. 10
Xiantao Zhibo Nonwoven Products Co., Ltd. 10
Xiantao Maosheng Plastic Products Co., Ltd. 10
Hubei Qifu Protective Products Co., Ltd. 9
Hubei Deming Healthcare Products Co., Ltd. 9
Hubei Deming Healthcare Products Co., Ltd.first Branch 9
Xiantao Xinfa Plastic Products Co., Ltd. 8
Hubei Yi-Ya Protective Products Co., Ltd. 8
Xiantao Hooray Protective Products Co., Ltd. 8
Fullstar NON-Woven Products Co., Ltd. 7
Xiantao Chenguang Protection Commodity Co Ltd 7
Xiantao Generalcare Protection Products Co., Ltd. 7
Xiantao Dingcheng Nonwoven Products Co., Ltd. 7
Xiantao Junhui Plastic Products Co., Ltd. 7
Xiantao Xingrong Protective Products Co., Ltd. 7
Xiantao Kimberly Protective Products Co., Ltd. 7
Hubei Origincare Medical Products Co., Ltd. 6
Xiantao Yunxiang Protective Products Co., Ltd. 6
Hubei Xianmeng Health Protection Commodity.,ltd 6
Xiantao Junlong Protective Products Co., Ltd. 6
Hubei Yazhi Hygiene Products Co., Ltd. 6
Hubei Kangning Protective Products Co., Ltd. 6
Safeway Industry Healthcare 5
Xiantao City Songqing Plastic Products Co., Ltd. 5
Hubei Kimsoul Industrial Co., Ltd. 4
Hubei Lehong Protective Products Co., Ltd. 4
Topwide (Hubei) Medical Products Manufacturer 4
AMD Hubei Inc. 3
Beatles Medical Supplies (Xiantao) Co., Ltd. 2
Unibeauty (Hubei) Technology Co., Ltd. 1

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