# K061308: Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health 200, Inc.
- Decided: Jun 5, 2006 after 26 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 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 Gowns, Breathable Surgical Gowns, Breathable Surgical Gowns and O. R. Surgical Gowns: named in the summary without a submission number

## Most influential descendants
- K102652: Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns (2011), 8 descendants of its own
- K121152: Surgical Gown, SMS (2012), 7 descendants of its own
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants of its own
- K141467: Surgical Gown (2015), 1 descendant of its own
- K253003: Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (2026), 0 descendants of its own

## Recalls of this device
- Jan 11, 2020 · Class II · Z-1005-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1017-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1002-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1004-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1006-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- Jan 11, 2020 · Class II · Z-1008-2020: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

## Indications for use
Convertors® Surgical gowns are made from natural and synthetic materials that are 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. The gown is a single use disposable device intended for repackaging and sterilization before use. This single use product is a disposable non-sterile surgical gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide following the Validation and Routine Control under ANSI/AMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health, Inc, The exception for sterilization is that the SMS polyolefin reinforced gown, cannot under go steam sterilization. Steam sterilization may damage the impervious reinforcement on the gown. Ethylene Oxide is the only method of sterilization for this gown.

Source page: https://510kreport.com/device/K061308
Methodology: https://510kreport.com/methodology