Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008048818

FEI Number

3008048818

Entity Name

XIANTAO SANDA INDUSTRIAL CO., LTD

City/State/Country

Xiantao Hubei, CN

Establishment Address

No.46, East Of Huangjin Avenue,Xiantao, 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 Sanda Industrial Co., Ltd (Owner Number: 10030643)

Owner / Operator Contact Address

NO.46 GOLDEN AVENUE, 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

Surgical Face Mask MEDICAL NURSING PAD Face mask KN95 N95 Respirator Protective Mask MICROSURGERY SLEEVE KNIFE SLEEVE Sleeve Nursing Pad ULTI-MED SURGICAL CAP SURGICAL CAP BOUFFANT CAP Medical Face Mask Protective Mask Disposable Face Mask Dust Mask Surgical Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-12-18
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-07-25
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2010-03-18
NZJ	Respirator, N95, For Use By The General Public In Public Health Medical Emergencies	General Hospital	Class 2	880.6260	2020-12-03
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2009-10-27
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2013-01-20
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2009-10-27
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	2020-12-03

Official Correspondent

Leo Hu

US Agent Details

Bryan Wong Business: PUREVISION AI, INC. (DBA PURE GLOBAL) Email: us-agent@pureglobal.com Phone: (888) 7681688

Related Public Records

Same Entity

XianTao Sanda Industrial 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
3016247944	HYGENIX HEALTH SOLUTIONS LLC	Torrance, CA, US
3016765490	XIAMEN CHUANFUTANG PHARMACEUTICAL CO.,LTD	xiamen Fujian, CN
3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3002813051	IRIS USA INC	Pleasant Prairie, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008048818. Last updated year: 2026. Please use registration number 3008048818 when referencing this establishment in official correspondence.