Winner Medical Co., Ltd.
SHENZHEN Guangdong, CN
WINNER MEDICAL CO., LTD. appears in FDA device records in SHENZHEN Guangdong, CN. FDA records list 18 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Winner Medical Co., Ltd. between 2019 and 2025. The busiest year on record is 2023, with 8. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 8 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252001 | Collagen Wound Dressing | KGN | Substantially Equivalent | |
| K250082 | Procedure mask/Surgical mask/Face mask | FXX | Substantially Equivalent | |
| K231057 | Antibacterial Gel Wound Dressing | FRO | Substantially Equivalent | |
| K231564 | Skin and Wound Cleanser | FRO | Substantially Equivalent | |
| K231152 | Collagen Wound Dressing | KGN | Substantially Equivalent | |
| K221311 | Antibacterial Bandage | FRO | Substantially Equivalent | |
| K223232 | Procedure mask/Surgical mask/Face mask | FXX | Substantially Equivalent | |
| K221532 | PHMB Wound Dressing | FRO | Substantially Equivalent | |
| 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 | |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing | FRO | Substantially Equivalent | |
| K221720 | Extra Silver Gelling Fiber Dressing | FRO | Substantially Equivalent | |
| 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 | |
| K220194 | Procedure mask/Surgical mask/Face mask | FXX | Substantially Equivalent | |
| K210466 | Silver Gelling Fiber Dressing | FRO | Substantially Equivalent | |
| K202982 | Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) | FRO | Substantially Equivalent | |
| K192463 | PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | FRO | Substantially Equivalent | |
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | |
| K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing | FRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3030067857 | 3030067857 | WINNER MEDICAL CO., LTD. | 42F, Building No.2, HBC Huilong Business Center, North Station Community, Minzhi Street, Longhua District, SHENZHEN Guangdong 518131 CN | 2026 | and 15 more, listed in full below |
| 9616433 | 3005076849 | WINNER MEDICAL CO., LTD. | Winner Industrial Park, No. 660 Bulong Road, SHENZHEN Guangdong 518109 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FQMBandage, Elastic
- NECBandage, Liquid, Skin Protectant
- FYFCap, Surgical
- EFNCotton, Roll
- PUIDrape, Surgical, Exempt
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NACDressing, Wound, Hydrophilic
- NADDressing, Wound, Occlusive
- MDAElastomer, Silicone, For Scar Management
- FRLFiber, Medical, Absorbent
- NABGauze / Sponge,Nonresorbable For External Use
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FYAGown, Surgical
- QUFHearing Aid, Air-Conduction, Over The Counter
- KDDKit, Surgical Instrument, Disposable
- FXXMask, Surgical
- OEANon-Surgical Gown
- LKBPad, Alcohol, Device Disinfectant
- HMPPad, Eye
- PORParenteral Administration Kit
- KOXSolvent, Adhesive Tape
- KGXTape And Bandage, Adhesive
- GAXTourniquet, Nonpneumatic
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain