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510(k) K250082

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

K250082 is an FDA 510(k) premarket notification submitted by Winner Medical Co., Ltd. for the device "Procedure mask/Surgical mask/Face mask". The FDA issued a decision of Substantially Equivalent on June 18, 2025. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Winner Medical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
January 13, 2025
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.

  • K252001 — Collagen Wound Dressing (October 10, 2025)
  • K231057 — Antibacterial Gel Wound Dressing (December 1, 2023)
  • 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 FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT (March 18, 2026)
  • K252534 — Surgical Face Mask (Ear mount) (March 3, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (February 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (January 12, 2026)
  • K252650 — Disposable Medical Face Mask (January 5, 2026)
  • 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)
  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)

FDA data resources