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510(k) K223823

Disposable Surgical Face Mask by Efofex, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2023
Date Received
December 21, 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 Efofex, Inc.

  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (February 19, 2026)

Other clearances for product code FXX

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  • 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)