# K111535: Emm Surgical Gown - Spunlace with PE Layer

- Pathway: 510(k) (Traditional)
- Applicant: Exact Medical Manufacturing, Inc.
- Decided: Aug 26, 2011 after 85 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 K964142 (1997). 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)
- K964142: Medline Disposable Surgical Drapes and Gowns, Medline Industries, Inc. (1997) Summary page 1.

## Indications for use
Exact Medical Manufacturing Surgical Gown - Spunlace wIPE Layer 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. The Exact Medical Manufacturing Surgical Gown - Spunlace wIPE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.

Source page: https://510kreport.com/device/K111535
Methodology: https://510kreport.com/methodology