# K150598: Blockade Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 28, 2016 after 416 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K201351: Maxima Surgical Gown (2022), 0 descendants of its own

## Indications for use
The Blockade reusable surgical gown is intended to be used 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. The Blockade reusable surgical gown is provided non-sterile. Sterilization parameters are as follows: * Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time) Medline Item Numbers / gown color / liq. barrier protection / gown size MDTGBS3CL / Ceil / AAMI Level 3 / Large MDTGBS3CXL / Ceil / AAMI Level 3 / X-Large MDTGBS3C2X / Ceil / AAMI Level 3 / XX-Large MDTGBS3JL / Jade / AAMI Level 3 / Large MDTGBS3JXL / Jade / AAMI Level 3 / X-Large MDTGBS3J2X / Jade / AAMI Level 3 / XX-Large

Source page: https://510kreport.com/device/K150598
Methodology: https://510kreport.com/methodology