# K020593: Convertors SMS Polyolefin Gown

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Mar 18, 2002 after 24 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 2 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)
- None. The FDA summary names its predicate without a number.
- (no number) Convertors®SMS Polyolefin Standard, Fabric and Poly-reinforced Gowns: named in the summary without a submission number

## Most influential descendants
- K170762: Cardinal Health Non-Reinforced Surgical Gown (2017), 19 descendants of its own
- 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

## Recalls of this device
- Nov 2, 2021 · Class II · Z-0373-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Nov 2, 2021 · Class II · Z-0374-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Nov 2, 2021 · Class II · Z-0378-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Nov 2, 2021 · Class II · Z-0372-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Nov 2, 2021 · Class II · Z-0375-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Nov 2, 2021 · Class II · Z-0376-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Nov 2, 2021 · Class II · Z-0377-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Jan 11, 2020 · Class II · Z-1011-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1013-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1022-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1024-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1040-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1010-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1014-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1023-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1026-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1027-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1034-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1035-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1036-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1009-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1012-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1025-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

## Indications for use
The Convertors®SMS Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K020593
Methodology: https://510kreport.com/methodology