Home / 510(k) Clearances / K170762

510(k) K170762

Cardinal Health Non-Reinforced Surgical Gown by Cardinal Health200, LLC — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2017
Date Received
March 13, 2017
Clearance Type
Traditional
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 Health200, LLC

  • K241780 — Cardinal Health Nitrile Exam Gloves (August 23, 2024)
  • K230838 — Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrumen (July 27, 2023)
  • K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject M (June 21, 2023)
  • K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD E (April 3, 2023)
  • K201592 — Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove (September 26, 2021)
  • K211390 — Nitrile Blue Powder-free Examination Glove (August 28, 2021)
  • K200824 — Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AI (July 29, 2020)
  • K193327 — Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health Chemo (March 20, 2020)
  • K192374 — Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip (December 2, 2019)
  • K182830 — Cardinal HealthTM Poly-Coated Open-Back Protective Gown (April 26, 2019)

Other clearances for product code FYA

  • 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)
  • K241214 — ProPel SG3™ Surgical Gown (September 10, 2024)
  • K233571 — GCI Surgical Gown (August 2, 2024)
  • K233068 — Disposable Surgical Gown (March 29, 2024)