Cardinal Health Isolation Gown— 510(k) K160339
Substantially EquivalentCardinal Health200, LLC
FDA 510(k) clearance K160339 for Cardinal Health Isolation Gown, Substantially Equivalent on 2016-07-28. Applicant: Cardinal Health200, LLC. Device class: 2.
Clearance details
- Applicant
- Cardinal Health200, LLC
- Product code
- Code FYC
- 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 FYC
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- K230135 — Copioumed Chemotherapy Isolation Gown
- K223467 — Disposable Isolation Gown
- K223304 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
- K223411 — Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
More clearances from Cardinal Health200, LLC
view all- K241780 — Cardinal Health Nitrile Exam Gloves
- K230838 — Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
- K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) +2 more
- K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
- K201592 — Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
Recalls naming K160339
K-number listed on FDA's recall record- Z-0674-2025 — Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
- Z-0675-2025 — Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160339.
Data sourced from openFDA. This site is unofficial and independent of the FDA.