# K070078: Stryker T4 Hytrel Toga - Pathway: 510(k) (Special) - Applicant: Stryker Instruments, Instruments Div. - Decided: Feb 2, 2007 after 24 days - Product code: FYA (Gown, Surgical) - Device class: 2 - Regulation: 21 CFR 878.4040 - Recalls of this device: 27 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K944393 (1995). 3 ancestors in all. No later device cites it as a predicate yet. 0 of 4 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K040764: Stryker T4 Hytrel Zipper Toga, Stryker Corp. (2004) Summary page 1. - K011755: Stryker T4 Hytrel (R) Togas, Stryker Corp. (2001) - K944393: Stryker Steri-Shield Surgical Apparel, Stryker Corp. (1995) Summary page 1. ## Recalls of this device - Feb 23, 2018 · Class II · Z-1510-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1506-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1502-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1507-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1509-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1504-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1503-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1500-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1505-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1501-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - Feb 23, 2018 · Class II · Z-1508-2018: Separation of material layers may occur, causing a potential risk of exposure to contaminants. - May 23, 2013 · Class II · Z-1496-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1492-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1490-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1498-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1501-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1499-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1493-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1500-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1497-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1494-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1491-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1503-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1489-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1504-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1495-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for - May 23, 2013 · Class II · Z-1502-2013: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for ## Indications for use The Stryker T4 Hytrel Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. Source page: https://510kreport.com/device/K070078 Methodology: https://510kreport.com/methodology