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510(k) K223232

Procedure mask/Surgical mask/Face mask by Winner Medical Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2023
Date Received
October 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Winner Medical Co., Ltd.

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  • K231152 — Collagen Wound Dressing (October 12, 2023)
  • K221311 — Antibacterial Bandage (June 21, 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 FXX

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  • K243342 — KP Protective Face Mask (December 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (December 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (September 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)