Home / 510(k) Clearances / K230569

510(k) K230569

Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) by Cardinalhealth — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2023
Date Received
March 1, 2023
Clearance Type
Abbreviated
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 Cardinalhealth

  • K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff (January 14, 2026)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K243652 — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syring (December 19, 2024)
  • K213174 — Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (May 19, 2022)
  • K202217 — Kendall NPWT Incision Management Device (June 4, 2021)
  • K191101 — Kendall NPWT Incision Management Dressing Kit (July 31, 2020)
  • K190923 — Salem Sump Dual Lumen Stomach Tube with ENFit Connection (November 7, 2019)
  • K171499 — Occlusion Detection Dressing Kit (September 22, 2017)
  • K161418 — Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Deli (January 19, 2017)
  • K150769 — Cardinal Health Trochanteric IM Nail System (December 14, 2015)

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)