SmartGownTM surgical gown— 510(k) K150151
Substantially EquivalentCardinal Health 200, Inc.
FDA 510(k) clearance K150151 for SmartGownTM surgical gown, Substantially Equivalent on 2015-05-21. Applicant: Cardinal Health 200, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardinal Health 200, Inc.
- Product code
- 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
- Traditional
- 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)
More clearances from Cardinal Health 200, Inc.
view allRecalls naming K150151
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150151.
Data sourced from openFDA. This site is unofficial and independent of the FDA.