# K212504: Isolation Gown AAMI Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Kenpax International Limited
- Decided: Nov 7, 2021 after 90 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.
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
The Isolation Gown AAMI Level 3 is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care FacilitiestANSI/AAMI PB70). The Isolation Gown is single use, disposable medical device provided non-sterile.

Source page: https://510kreport.com/device/K212504
Methodology: https://510kreport.com/methodology