Data / Medical devices / China / Winner Medical Co., Ltd.
Winner Medical Co., Ltd.: FDA-registered device maker in SHENZHEN Guangdong, China, 18 510(k) clearances
Winner Medical Co., Ltd. is registered with the FDA (registration 3030067857) in SHENZHEN Guangdong, China. It lists 25 device types. The FDA files 18 510(k) clearances under its listings, the newest dated October 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030067857
- Address
- 42F, Building No.2, HBC Huilong Business Center, North Station Community, Minzhi Street, Longhua District, SHENZHEN Guangdong, China, 518131
- Owner or operator
- WINNER MEDICAL CO., LTD. (9012349)
- Roles
- Exporter to the US, Specification developer
- First device listed
- January 24, 2000
- Registered through
- 2026
- Brand names listed
- ADHESIVE TAPE AND BANDAGE, ALMORIS Alginate Wound Dressing, ATHLETIC TAPE, Absorbent drape, Absorbent towel, Activated Charcoal Super Absorbent Dressing, Adhesive Romover Wipes, Ag Foam Dressing Adhesive and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 2025 | K252001 | Collagen Wound Dressing | KGN | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| June 18, 2025 | K250082 | Procedure mask/Surgical mask/Face mask | FXX | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| December 1, 2023 | K231057 | Antibacterial Gel Wound Dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| November 10, 2023 | K231564 | Skin and Wound Cleanser | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| October 12, 2023 | K231152 | Collagen Wound Dressing | KGN | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| March 6, 2023 | K223232 | Procedure mask/Surgical mask/Face mask | FXX | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| January 30, 2023 | K221532 | PHMB Wound Dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| January 17, 2023 | K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| January 13, 2023 | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| December 21, 2022 | K221720 | Extra Silver Gelling Fiber Dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| September 19, 2022 | K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown | FYA | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| May 17, 2022 | K220194 | Procedure mask/Surgical mask/Face mask | FXX | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| January 14, 2022 | K210466 | Silver Gelling Fiber Dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| October 19, 2021 | K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| May 14, 2020 | K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| May 14, 2020 | K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| February 14, 2019 | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| November 3, 1989 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | Substantially Equivalent | Ashton Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Fiber, Medical, Absorbent
- All makers of Bandage, Elastic
- All makers of Kit, Surgical Instrument, Disposable
- All makers of Cap, Surgical
- All makers of Dressing, Wound, Drug
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.