Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016989300

FEI Number

3016989300

Entity Name

YIWU RUOXUAN GARMENT CO.,LTD

City/State/Country

Jinhua Zhejiang, CN

Establishment Address

NO.23 SHUANGFENG ROAD,YIWU SOUTH INDUSTRIAL ZONE, YIWU CITY, Jinhua Zhejiang 322000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

YIWU RUOXUAN GARMENT CO.,LTD (Owner Number: 10069699)

Owner / Operator Contact Address

NO.23 SHUANGFENG ROAD,YIWU SOUTH INDUSTRIAL ZONE, YIWU CITY, Jinhua, CN-ZJ 322000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Bouffant Caps;Disposable Isolation Caps Disposable Protective Isolation Coverall(non-sterile) Disposable Isolation gown (non-sterile) Disposable Isolation Coverall(non-sterile) Surgical Gown Protective Coverall Instrument Protector Disposable Scrubs; Brush Disposable Overshoes Disposable non-woven fabric cap Instrument, Manual, Surgical, General Use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-11-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-14
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-05-29
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-05-29
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-09-14
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2020-11-08
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-04-14
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	2020-04-14

Official Correspondent

Xiaobin Zhu

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

YIWU RUOXUAN GARMENT CO.,LTD

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016989300. Last updated year: 2026. Please use registration number 3016989300 when referencing this establishment in official correspondence.