Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011587065

FEI Number

3011587065

Entity Name

XIANTAO JUNHUI PLASTIC PRODUCTS CO.,LTD.

City/State/Country

Xiantao Hubei, CN

Establishment Address

CENTURT AVENUE,PENGCHANG TOWN, Xiantao Hubei 433000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Xiantao Junhui Plastic Products Co.,Ltd. (Owner Number: 10048518)

Owner / Operator Contact Address

CENTURT AVENUE,PENGCHANG TOWN, XIANTAO, CN-HB 433000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Examination Gown Protective Face Mask stethoscope Extra Traction Shoe Covers CPE GOWNS non-surgical Isolation Gown Mask w/Fluidshield 50pcs/box, 4 box/carton Mask Isolation Molded 50pcs/box, 20boxes/carton Mask Flat Isolation 50/pcs box, 12boxes/carton Surgical Apparel Accessory DISPOSABLE SURGRICAL CAPS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FME	Gown, Examination	General Hospital	Class 1	880.6265	2015-01-22
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	2022-02-13
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2016-07-14
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2016-03-09
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2015-01-22
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2017-04-17
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-08-29

Official Correspondent

Jun Li

US Agent Details

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

Related Public Records

Same Entity

Xiantao Junhui Plastic Products Co.,Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011587065. Last updated year: 2026. Please use registration number 3011587065 when referencing this establishment in official correspondence.