Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012268821

FEI Number

3012268821

Entity Name

XIANTAO TOPMED NONWOVEN PROTECTIVE PRODUCTS CO., LTD

City/State/Country

xiantao Hubei, CN

Establishment Address

North of the National Road 318, Dongjiazui Village,Huchang Town, xiantao 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 Topmed Nonwoven Protective Products Co., Ltd (Owner Number: 10081073)

Owner / Operator Contact Address

North of the National Road 318, Dongjiazui Village,Huchang Town, xiantao, CN-HB 433000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable pillow case, Disposable blanket BED SHEET, BED COVER, BED SHEET ROLL,DENTAL SHEET Nonwoven gauze Disposable Surgical Gown (G4003) BOOT COVER, DISPOSABLE SLIPPER,SLEEVE COVER, SHOE COVER CAP/DISPOSABLE CAP/NONWOVEN CAP/MOB CAP CLIP CAP/ROUND CAP,NURSE CAP,BALACLAVE CAP, SURGICAL CAP Dental bib Diaper

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-05-16
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-03-15
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-05-16
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-11-11
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2021-03-15
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-03-15
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2023-09-28
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2023-09-28

Official Correspondent

RONG ZHU

US Agent Details

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

Related Public Records

Same Entity

Xiantao Topmed Nonwoven Protective 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Similar Registrations

Registration Number	Establishment Name	Location
3011189534	DS TEXTILE PRODUCTS, INC.	Gulf Shores, AL, US
3040278131	Ozuufuk Tekstil Ith. Ihr. San. Ve Tic. Ltd. Sti	Istanbul, TR
3013682767	SAVE MY FACE, INC.	Valencia, CA, US
3016752930	ZEN LINEN INTERNATIONAL PRIVATE LIMITED.	Chennai Tamil Nadu, IN
3043051417	SUNING JUNQI MEDICAL HYGIENE PRODUCTS (CAMBODIA) CO., LTD.	Kampong Soam Preah Sihanouk, KH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012268821. Last updated year: 2026. Please use registration number 3012268821 when referencing this establishment in official correspondence.