Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007966889

FEI Number

3007966889

Entity Name

Winner Medical (Huanggang) Co., Ltd.

City/State/Country

Huanggang Hubei, CN

Establishment Address

Winner Industrial Park, Te1,Chibi Road, Huanggang Hubei 438000, CN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

WINNER MEDICAL CO., LTD. (Owner Number: 9012349)

Owner / Operator Contact Address

42nd Floor, Building No.2, Huilong Business Center, Longhua District, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K895077

PMA Number

N/A

All Registered Proprietary Names

PHMB Foam Dressing PHMB non-adhesive foam dressing PHMB sacral bordered silicone foam dressing with SAF PHMB bordered foam dressing PHMB bordered silicone foam dressing with SAF LARGE STERILE GAUZE PAD PC swabs without X-ray thread Conforming stretch gauze DRYNET Medical Mask Procedure Mask Surgical Face Mask Earloops Face Mask Face Mask Medical Face Mask Medical Face Mask Earloop Silicone Scar Repair Sheet Silicone Scar Gel Silicone Scar Gel Ultra Silicone Ag Foam Dressing Ag Foam Dressing Adhesive Silicone Ag Foam Dressing with Border Ag Foam Dressing Non-adhesive PC Towel Incontinence Underpads Absorbent towel Super Absorbent Dressing Alginate Dressing Nonwoven Adhesive wound dressing (Strip) CMC Gelling Fiber Dressing Wound Dressing ALMORIS Alginate Wound Dressing Activated Charcoal Super Absorbent Dressing Silicone Super Absorbent Dressing transparent dressing Silicone Absorbent Soft Dressing with border HidraWear Superabsorbent Dressing Calcium Alginate Wound Dressing Transparent Dressing Sacrum Silicone Foam Dressing with Border Silicone Contact Layer Transparent Film Dressing Foam Dressing Silicone Foam Dressing Hydrocolloid Dressing Silicone Foam Dressing with Border ALMORIS Silicone Foam Dressing Foam dressing without border Silicone Foam Dressing without Border Dimora HEEL FOAM DRESSING Without Borde HidraWear Foam Dressing Hydrocolloid (Sterile Wound Dressing with Border) Waterproof Foam Dressing Hydrocolloid Roll Procedure mask/Surgical mask/Face mask Surgical Face Mask Medical Earloop Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-04-14
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2010-05-07
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-07-15
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2020-08-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-20
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2002-05-07
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-08-06
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2013-01-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-30
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-08-25

Official Correspondent

Xiaomeng Yang

US Agent Details

DAVID LENNARZ Business: REGISTRAR CORP Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

WINNER MEDICAL CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3035744034	NATURE HEALTH DEVELOPMENT(HONG KONG)CO.,LIMITED	Hong Kong, CN
3031238659	Winner Medical Co., Ltd., Shenzhen Branch	Shenzhen Guangdong, CN
9616433	WINNER MEDICAL CO., LTD.	SHENZHEN Guangdong, CN
3008132238	Winner Medical (Jiayu) Co., Ltd.	Jiayu Hubei, CN
3030067857	WINNER MEDICAL CO., LTD.	SHENZHEN Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

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
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007966889. Last updated year: 2026. Please use registration number 3007966889 when referencing this establishment in official correspondence.