# K993170: Medline Breathable, Impervious Disposable Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 2, 2000 after 162 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
Medline Breathable, Impervious Surgical Gowns are single-use gowns intended to be worn by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K993170
Methodology: https://510kreport.com/methodology