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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 Mar 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
Mar 3, 2026
Date Received
Aug 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 (Mar 18, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (Feb 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (Jan 12, 2026)
  • K252650 — Disposable Medical Face Mask (Jan 5, 2026)
  • K243342 — KP Protective Face Mask (Dec 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (Dec 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (Nov 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (Sep 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (Jun 18, 2025)
  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)

FDA data resources