Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680455

FEI Number

3002808274

Entity Name

SUZHOU AVON TEXTILE CO., LTD.

City/State/Country

Suzhou City Jiangsu, CN

Establishment Address

No.168, Tongcheng Road, Weitang Town, Xiangcheng Region, Suzhou City Jiangsu 215100, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SUZHOU AVON TEXTILE CO., LTD. (Owner Number: 9009195)

Owner / Operator Contact Address

Yuanhe Town, Xiangcheng Region, --, Suzhou, Jiangsu Province, CN-NOTA 215133, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2020-06-03
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-06-23
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-05-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2012-02-27
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-06-03
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-01-23
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-10-12
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2008-01-10
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-05-24
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-11-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	1994-04-12
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2007-12-10
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2010-03-02
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2011-11-18

Official Correspondent

Yong Shu Li

US Agent Details

Solomon Chen Email: SOLOMON@APLUSGROUP.NET Phone: (909) 4387898

Related Public Records

Same Entity

SUZHOU AVON TEXTILE 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K861444	Surgical Specialties, Inc.	S1 NASAL PACKING	1986-05-06
K863737	Hermitage Hospital Products, Inc.	SPONGES STERILE TWIN PAKT AND SINGLES	1986-10-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3014819517	WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD.	Suzhou Jiangsu, CN
3005078659	NAN'AN HENGYUAN HYGIENE PRODUCTS CO., LTD.	Nanan Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680455. Last updated year: 2026. Please use registration number 9680455 when referencing this establishment in official correspondence.