Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012595397

FEI Number

3012595397

Entity Name

DONGHAI XINGCHEN NON-WOVEN PRODUCTS CO., LTD.

City/State/Country

North Donghai Development Zone, Lianyungang Jiangsu, CN

Establishment Address

Standard Factory Premises 7-8, West of Xingchen Road & North of Shunfa Rd., North Donghai Development Zone, Lianyungang Jiangsu 222323, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Donghai Xingchen Non-Woven Products Co., Ltd. (Owner Number: 10051507)

Owner / Operator Contact Address

Standard Factory Premises 7-8, West of Xingchen Rd. & North of Shunfa Rd., North Donghai Development Zone, Lianyungang, CN-JS 222323, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

A Plus International, Inc. Non-woven Surgical Apparel A Plus International, Inc. Fluid Control Towels

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-05-31
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-05-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2016-03-28
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-05-31
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-01-26
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-03-28
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-01-02

Official Correspondent

Xuefeng Zhang

US Agent Details

Solomon Chen Email: solomon@aplusgroup.net Phone: (909) 5915168

Related Public Records

Same Entity

Donghai Xingchen Non-Woven 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012595397. Last updated year: 2026. Please use registration number 3012595397 when referencing this establishment in official correspondence.