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510(k) K231057

Antibacterial Gel Wound Dressing by Winner Medical Co., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2023
Date Received
April 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Winner Medical Co., Ltd.

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  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
  • K231564 — Skin and Wound Cleanser (November 10, 2023)
  • K231152 — Collagen Wound Dressing (October 12, 2023)
  • K221311 — Antibacterial Bandage (June 21, 2023)
  • K223232 — Procedure mask/Surgical mask/Face mask (March 6, 2023)
  • K221532 — PHMB Wound Dressing (January 30, 2023)
  • K221754 — Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone A (January 17, 2023)
  • K221755 — Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimi (January 13, 2023)
  • K221720 — Extra Silver Gelling Fiber Dressing (December 21, 2022)

Other clearances for product code FRO

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  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)
  • K250890 — SBC1 Cream (January 12, 2026)
  • K252759 — revyve® Antimicrobial Skin and Wound Cleanser (January 8, 2026)
  • K251757 — Puracyn® Plus Antimicrobial Irrigation Solution (January 5, 2026)
  • K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber (December 19, 2025)
  • K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (November 19, 2025)
  • K250115 — Hemastyl(™) Wound Dressing (October 14, 2025)