Chrysalis Intelligence · Sponsors · Winner Medical Co., Ltd.

Winner Medical Co., Ltd.

Shenzhen, CN · 17 510(k) clearances

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Total clearances
17
2020-05-14 → 2025-10-10
Last 12 months
1
Product codes
4
Most recent
2025-10-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FRO Dressing, Wound, Drug Unclassified Unknown 11 2023-12-01
FXX — — — 3 2025-06-18
KGN Wound Dressing With Animal-Derived Material(S) Unclassified Unknown 2 2025-10-10
FYA Gown, Surgical Class II General, Plastic Surgery 1 2022-09-19
Filings

All 510(k) clearances (17)

Date K-number Device Code Class Specialty
2025-10-10 K252001 Collagen Wound Dressing KGN Unclassified Unknown
2025-06-18 K250082 Procedure mask/Surgical mask/Face mask FXX — —
2023-12-01 K231057 Antibacterial Gel Wound Dressing FRO Unclassified Unknown
2023-11-10 K231564 Skin and Wound Cleanser FRO Unclassified Unknown
2023-10-12 K231152 Collagen Wound Dressing KGN Unclassified Unknown
2023-06-21 K221311 Antibacterial Bandage FRO Unclassified Unknown
2023-03-06 K223232 Procedure mask/Surgical mask/Face mask FXX — —
2023-01-30 K221532 PHMB Wound Dressing FRO Unclassified Unknown
2023-01-17 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 Unclassified Unknown
2023-01-13 K221755 Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing FRO Unclassified Unknown
2022-12-21 K221720 Extra Silver Gelling Fiber Dressing FRO Unclassified Unknown
2022-09-19 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 Class II General, Plastic Surgery
2022-05-17 K220194 Procedure mask/Surgical mask/Face mask FXX — —
2022-01-14 K210466 Silver Gelling Fiber Dressing FRO Unclassified Unknown
2021-10-19 K202982 Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) FRO Unclassified Unknown
2020-05-14 K192463 PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border FRO Unclassified Unknown
2020-05-14 K191819 Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border FRO Unclassified Unknown
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence