# K252575: Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)

- Pathway: 510(k) (Traditional)
- Applicant: New York Embroidery Studio (NYES)
- Decided: Jun 4, 2026 after 294 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Tuff Cuff™ Disposable Surgical Gown is 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. Per ANSI/AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Tuff Cuff™ Disposable Surgical Gowns met the requirements for Level 4 classification. The Tuff Cuff™ Disposable Surgical Gown is single-use, disposable medical device, and are provided sterile.

Source page: https://510kreport.com/device/K252575
Methodology: https://510kreport.com/methodology