Cardinal Health Poly Reinforced Surgical Gown— 510(k) K253243
Substantially EquivalentCardinal Health 200, LLC
FDA 510(k) clearance K253243 for Cardinal Health Poly Reinforced Surgical Gown, Substantially Equivalent on 2026-04-28. Applicant: Cardinal Health 200, LLC. Device class: 2.
Summary
The Cardinal Health Poly Reinforced Surgical Gown, from Cardinal Health 200, LLC, is filed under product code FYA (Gown, Surgical).
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as an Abbreviated 510(k), though the record lists General and Plastic Surgery as the classification panel.
Cardinal Health filed from Waukegan, Illinois. The record shows 211 calendar days from receipt to decision (September 29, 2025 to April 28, 2026).
Clearance details
- Applicant
- Cardinal Health 200, LLC
- Product code
- Product code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Waukegan, IL, US
Recent devices under product code FYA
view all- K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
Data sourced from openFDA. This site is unofficial and independent of the FDA.