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510(k) K252534

Surgical Face Mask (Ear mount) by Zhejiang Hangkang Medical Equipment Co., Ltd. — Product Code FXX

K252534 is an FDA 510(k) premarket notification submitted by Zhejiang Hangkang Medical Equipment Co., Ltd. for the device "Surgical Face Mask (Ear mount)". The FDA issued a decision of Substantially Equivalent on March 3, 2026. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2026
Date Received
August 12, 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 for product code FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT (March 18, 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)
  • 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)

FDA data resources