Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017494285

FEI Number

3017494285

Entity Name

XIANTAO GENERALCARE PROTECTION PRODUCTS CO.,LTD

City/State/Country

Xiantao City Hubei, CN

Establishment Address

9D Huangjin Village, Xiantao City Hubei 433000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Xiantao GeneralCare Protection Products Co.,Ltd (Owner Number: 10077591)

Owner / Operator Contact Address

9D Huangjin Village, 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

surgical suit coverall face mask lab coat visitor gown shoe cover disposable bed sheet disposable bed cover pe spa liner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-09-05
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	2020-09-05
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-09-05
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2025-11-21
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-09-05

Official Correspondent

Kevin Huang

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

Xiantao GeneralCare Protection 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 3017494285. Last updated year: 2026. Please use registration number 3017494285 when referencing this establishment in official correspondence.