# K160339: Cardinal Health Isolation Gown

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Jul 28, 2016 after 171 days
- Product code: FYC (Gown, Isolation, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952116 (1995). 1 ancestor in all.
16 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952116: Cover Gown, American Threshold Industries, Inc. (1995) Summary page 4.

## Most influential descendants
- K190306: AMD Ritmed AssureWear VersaGown (2020), 6 descendants of its own
- K202310: Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back (2021), 5 descendants of its own
- K210785: Disposable Surgical Gowns (2021), 3 descendants of its own
- K203415: Surgical Isolation Gown (2021), 1 descendant of its own
- K171535: Surgical Isolation Gown (2018), 1 descendant of its own

## Recalls of this device
- Nov 1, 2024 · Class II · Z-0675-2025: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instr
- Nov 1, 2024 · Class II · Z-0674-2025: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instr

## Indications for use
Cardinal HealthTM Isolation Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Cardinal HealthTM Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Cardinal HealthTM Isolation Gown is a single use, disposable medical device provided non-sterile.

Source page: https://510kreport.com/device/K160339
Methodology: https://510kreport.com/methodology