Home / 510(k) Clearances / K253243

510(k) K253243

Cardinal Health™ Poly Reinforced Surgical Gown by Cardinal Health 200, LLC — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2026
Date Received
September 29, 2025
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Cardinal Health 200, LLC

  • K151778 — Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydr (March 24, 2016)
  • K150151 — SmartGownTM surgical gown (May 21, 2015)
  • K061308 — TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIM (June 5, 2006)

Other clearances for product code FYA

  • K252575 — Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) (June 4, 2026)
  • K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (May 12, 2026)
  • K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); (April 20, 2026)
  • K251860 — Copioumed AAMI 3 Surgical Gown (February 26, 2026)
  • K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced) (February 4, 2026)
  • K250564 — Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (December 3, 2025)
  • K243522 — ViVi® Toga Premium (May 30, 2025)
  • K242937 — Dream Medi Sterile Surgical Gown (SurgicalGownUL) (May 5, 2025)
  • K242844 — Medline Level 4 Surgical Gown with Breathable Sleeves (February 26, 2025)
  • K241272 — Stryker Steri-Shield 8 Surgical Hoods and Togas (October 16, 2024)