# K221027: Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

- Pathway: 510(k) (Traditional)
- Applicant: Allmed Medical (Hubei) Protective Products Co., Ltd.
- Decided: Aug 12, 2022 after 128 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 K952116 (1995). 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)
- K160339: Cardinal Health Isolation Gown, Cardinal Health200, LLC (2016) Summary page 4.

## Indications for use
The Isolation Gowns are 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 Gowns meet 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 and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical device provided non-sterile.

Source page: https://510kreport.com/device/K221027
Methodology: https://510kreport.com/methodology