Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017597597

FEI Number

3017597597

Entity Name

JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,LTD

City/State/Country

Jingzhou Hubei, CN

Establishment Address

Yongxing North Road No.2, Jingzhou Hubei 434200, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Jingzhou Haixin Green Cross Medical Products Co.,Ltd (Owner Number: 10078959)

Owner / Operator Contact Address

Yongxing North Road No.2, Jingzhou, CN-HB 434200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GOWN, ISOLATION, SURGICAL Bouffant Cap Surgical Mask (Gfm 96, Gfm 91, Gfm 90, Gfm 88, Gfm 81, Gfm 80) Face Shield Cover Gown; Coverall; Impervious Gown; Isolation Gown; Lab Coat; Lab Jacket; Thumbloop Gown; Non-Surgical Isolation Gown Suit Surgical Isolation Gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-11-12
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-11-12
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-11-30
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-11-12
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-11-12
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-11-12
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-11-12

Official Correspondent

Radar Lei

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Jingzhou Haixin Green Cross Medical 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
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 3017597597. Last updated year: 2026. Please use registration number 3017597597 when referencing this establishment in official correspondence.