# K925077: Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers

- Pathway: 510(k) (Traditional)
- Applicant: Medtek Development Corp.
- Decided: Aug 16, 1993 after 313 days
- Product code: FYC (Gown, Isolation, 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K160337: Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns (2017), 5 descendants of its own
- K210405: ProTEC-USA EZDoff Gown (2021), 2 descendants of its own
- K233526: Medline Open-back Level 3 Protective Gown (2024), 1 descendant of its own
- K262007: PRIMED AAMI Level 3 Open Back Gowns (2026), 0 descendants of its own
- K203821: Donagamex Blue Performance Protective Gown (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K925077
Methodology: https://510kreport.com/methodology