# K212717: Paneffort AAMI Level 3 Isolation Gown

- Pathway: 510(k) (Traditional)
- Applicant: Paneffort, LLC
- Decided: Nov 30, 2022 after 460 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
Longest line of descent: 2 generations back to K981393 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160361: PRIMAGARD Isolation Gown (AAMI PB70 Level 3), Primed Medical Products, Inc. (2016) Summary page 5.

## Indications for use
The Paneffort AAMI Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Paneffort AAMI Level 3 Isolation Gowns meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.

Source page: https://510kreport.com/device/K212717
Methodology: https://510kreport.com/methodology