# K210405: ProTEC-USA EZDoff Gown

- Pathway: 510(k) (Traditional)
- Applicant: Cadillac Products, Inc.
- Decided: Dec 15, 2021 after 308 days
- Product code: QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection)
- 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
Longest line of descent: 2 generations back to K925077 (1993). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160337: Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns, Bam Corporation Limited (2017) Summary page 4.

## Most influential descendants
- 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

## Indications for use
ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

Source page: https://510kreport.com/device/K210405
Methodology: https://510kreport.com/methodology