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510(k) K252650

Disposable Medical Face Mask by Makrite Industries, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2026
Date Received
August 22, 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 Makrite Industries, Inc.

  • K240258 — Disposable Medical Face Mask (M643BE) (April 18, 2024)
  • K220550 — Disposable Surgical Face Mask (M663BE, M663BT) (June 14, 2022)
  • K020474 — MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 (July 23, 2002)

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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)
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  • 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)
  • K242502 — Aurelia Surgical Mask ASTM Level-3 (2130) (November 12, 2024)