Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017212217

FEI Number

3017212217

Entity Name

XIANNING FULL GUARD MEDICAL PRODUCTS CO.,LTD

City/State/Country

Xianning City Hubei, CN

Establishment Address

Fuqiao Village, Henggou Town, Xianan District, Xianning City Hubei 437000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xianning Fullguard Medical Products CO.,LTD (Owner Number: 10071684)

Owner / Operator Contact Address

Fuqiao Village, Henggou Town, Xianan District, Xianning City, CN-HB 437000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shoe Cover Shoe Cover Gown Surgical Dress Apparel Surgical Suit Surgical Helmet Shoe Cover

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	2020-04-30
FXW	Shoes, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-04-30
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-30
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-04-30
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-23
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-04-30
FXZ	Helmet, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-04-30
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-04-30

Official Correspondent

No official correspondent registered.

US Agent Details

william slevin Business: medapproval llc Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

Xianning Fullguard Medical 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 3017212217. Last updated year: 2026. Please use registration number 3017212217 when referencing this establishment in official correspondence.