# K120045: Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV

- Pathway: 510(k) (Traditional)
- Applicant: Exact Medical Manufacturing, Inc.
- Decided: Jun 12, 2012 after 158 days
- Product code: FYA (Gown, 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: 1 generation back to K992514 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992514: Convertors Breathable Surgical Gowns, Allegiance Healthcare Corp. (1999) Summary page 1.

## Indications for use
Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV are sterile or non-sterile single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Sterile surgical gowns are to be sold directly to users after EtO sterilization and validated to ISO 11135-1:2007. The Exact Medical Manufacturing Surgical Gowns with AAMI Level IV Liquid Barrier are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007

Source page: https://510kreport.com/device/K120045
Methodology: https://510kreport.com/methodology