# K920405: Sterile Surgeon's Gown

- Pathway: 510(k) (Traditional)
- Applicant: Amsco Sterile Recoveries, Inc.
- Decided: Aug 18, 1992 after 200 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K023635: Sri/Surgical Express SP Reusable Surgical Gown (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K920405
Methodology: https://510kreport.com/methodology