# K091097: Promedical Surgical Gown, Models 18-301, 18-401 and 18-501

- Pathway: 510(k) (Special)
- Applicant: Promedical Products Co., Ltd.
- Decided: May 27, 2009 after 41 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K093115: Kimberly-Clark KC100 Surgical Gown, Model KC100 (2010), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/K091097
Methodology: https://510kreport.com/methodology