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510(k) K210466

Silver Gelling Fiber Dressing by Winner Medical Co., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2022
Date Received
February 16, 2021
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

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  • 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)

Other clearances for product code FRO

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  • 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)