Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017419584

FEI Number

3017419584

Entity Name

HUBEI YAZHI HYGIENE PRODUCTS CO., LTD

City/State/Country

Xiantao City Hubei, CN

Establishment Address

South side of Shahu Avenue, Shahu Town, Xiantao City Hubei 433000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HUBEI YAZHI HYGIENE PRODUCTS CO ., LTD (Owner Number: 10076140)

Owner / Operator Contact Address

South side of Shahu Avenue, Shahu Town, Xiantao City, CN-HB 433000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shoe Cover; Boot Cover Disposable Gowns; Isolation Gown; Patient Gown; CPE Gown; Lab Coat; Coverall; Clothing; Pants; Non Woven Suits; Rain Coat; Apron Sleeve Cover; Beard Cover; Face Mask Body Bag; Non Woven Bags Disposable Bed Covers; Disposable Bed Sheets; Patient Transfer Sheets; Disposable Pillow Case; Disposable Underpads; Cap; Disposable Cap; Non woven Cap; Doctor Cap; Disposable Hoods Disposable face mask; Face mask with shield; Face shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-07-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-07-08
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-07-08
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-07-08
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-07-08
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	2020-07-08

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

HUBEI YAZHI HYGIENE PRODUCTS CO ., LTD

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

View Entity Profile →

Similar Registrations

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3008808082	PLANET(SHANGHAI) INTERNATIONAL CO.,LTD	shanghai, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017419584. Last updated year: 2026. Please use registration number 3017419584 when referencing this establishment in official correspondence.