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510(k) K232806

HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) by Owens & Minor (O&M) Halyard, Inc. — Product Code FXX

K232806 is an FDA 510(k) premarket notification submitted by Owens & Minor (O&M) Halyard, Inc. for the device "HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)". The FDA issued a decision of Substantially Equivalent on June 7, 2024. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Owens & Minor (O&M) Halyard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2024
Date Received
September 12, 2023
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 Owens & Minor (O&M) Halyard, Inc.

  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)
  • K232824 — FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloop (July 2, 2024)
  • K232777 — FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavend (July 1, 2024)
  • K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); (June 21, 2024)
  • K232812 — Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical (June 14, 2024)
  • K232820 — HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) (June 4, 2024)
  • K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI (May 16, 2024)
  • K233022 — Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with S (January 12, 2024)
  • K232894 — HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (January 8, 2024)
  • K214007 — HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap (July 27, 2022)

Other clearances for product code FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT (March 18, 2026)
  • 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)

FDA data resources