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510(k) K240286

PRIMED Surgical Masks and PRIMED Procedure Masks by Primed Medical Products, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2024
Date Received
February 1, 2024
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 Primed Medical Products, Inc.

  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K242208 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (October 7, 2024)
  • K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (May 24, 2024)
  • K213427 — PRIMED Pediatric Facemask (November 22, 2022)
  • K160361 — PRIMAGARD Isolation Gown (AAMI PB70 Level 3) (November 4, 2016)
  • K092012 — PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL (September 25, 2009)
  • K081633 — PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS (August 11, 2008)

Other clearances for product code FXX

  • 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)
  • 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)