Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008240985

FEI Number

3008240985

Entity Name

XIANNING ECO MEDICAL ARTICLES CO., LTD.

City/State/Country

Xianning Hubei, CN

Establishment Address

No.16,Shutai Street, High-tech industrial zone, Xianning Hubei 437000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Xianning Eco Medical Articles Co., Ltd. (Owner Number: 10031508)

Owner / Operator Contact Address

No.16,ShuTai Street, High-tech industrial zone, Xianning, CN-HB 437000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline Surgical Face Mask and Medline Procedural Face Mask DISPOSABLE SURGICALBOUFFANT CAP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-21
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-02-08

Official Correspondent

Wei Zhou

US Agent Details

James Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Xianning Eco Medical Articles 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 3008240985. Last updated year: 2026. Please use registration number 3008240985 when referencing this establishment in official correspondence.