Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008756535

FEI Number

3008756535

Entity Name

FULLSTAR NON-WOVEN PRODUCTS CO.,LTD.

City/State/Country

Xiantao City Hubei, CN

Establishment Address

Gongtong Industrial Zone, Pengchang Ave., Xiantao City Hubei -, CN

Establishment Type(s)

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

Owner / Operator

Fullstar Non-Woven Products Co.,Ltd. (Owner Number: 10034785)

Owner / Operator Contact Address

Gongtong Industrial Zone, Pengchang Ave., Xiantao City, CN-HB -, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scavenging Mask Surgical suit Examination Gown Face Mask Operating-Room Shoe Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2010-12-31
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2011-06-17
FME	Gown, Examination	General Hospital	Class 1	880.6265	2010-12-31
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	2021-12-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2010-12-31

Official Correspondent

Fu Weifeng

US Agent Details

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

Related Public Records

Same Entity

Fullstar Non-Woven 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 3008756535. Last updated year: 2026. Please use registration number 3008756535 when referencing this establishment in official correspondence.