# K170762: Cardinal Health Non-Reinforced Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Jun 9, 2017 after 88 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020593 (2002). 1 ancestor in all.
19 later devices descend from it; 8 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020593: Convertors SMS Polyolefin Gown, Allegiance Healthcare Corp. (2002) Summary page 4.

## Most influential descendants
- K190950: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) (2019), 5 descendants of its own
- K212591: Disposable Surgical Gown (2022), 2 descendants of its own
- K211509: Surgical Gown (2021), 2 descendants of its own
- K173847: Disposable Ultra Reinforced Surgical Gown (2019), 2 descendants of its own
- K222999: Surgical Gown (2023), 1 descendant of its own

## Recalls of this device
- Jan 11, 2020 · Class II · Z-1020-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1033-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1015-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1019-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1021-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1031-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1038-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1039-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1018-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1032-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1003-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1007-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1016-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1028-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1029-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1030-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1037-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

## Indications for use
Cardinal Health™ Non-Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Cardinal Health™ Non-Reinforced Surgical Gowns are single use, disposable medical devices; provided sterile and non-sterile.

Source page: https://510kreport.com/device/K170762
Methodology: https://510kreport.com/methodology