# K230577: Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

- Pathway: 510(k) (Traditional)
- Applicant: Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
- Decided: Aug 16, 2023 after 168 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 Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) is a sterile single-use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They have been tested and are classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

Source page: https://510kreport.com/device/K230577
Methodology: https://510kreport.com/methodology