# K222128: Protective Gown AAMI Level 4

- Pathway: 510(k) (Traditional)
- Applicant: Kenpax International Limited
- Decided: Aug 8, 2023 after 386 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Protective gown AAMI Level 4 is intended to protect health care personnel and patients from transfer of microorganisms, body fluids and particulate material. The Protective Gowns 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/K222128
Methodology: https://510kreport.com/methodology