# K212633: Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue

- Pathway: 510(k) (Traditional)
- Applicant: String King Lacrosse, LLC
- Decided: Nov 24, 2021 after 97 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: 3 generations back to K952116 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202310: Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back, Wildcat Ppe, LLC (2021) Summary page 4.

## Indications for use
The StringKing Disposable Isolation Gown is intended to protect health care personnel and health care patients from the transfer of microorganisms, body fluids and particulate material. These gowns are not intended for use in the operating room. The StringKing Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The String King Disposable Isolation Gown is a single use, disposable medical device and is provided non-sterile.

Source page: https://510kreport.com/device/K212633
Methodology: https://510kreport.com/methodology