# K201351: Maxima Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Elevate Textiles
- Decided: Mar 11, 2022 after 659 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 K150598 (2016). 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)
- K150598: Blockade Surgical Gown, Medline Industries, Inc. (2016) Summary page 4.

## Indications for use
The reusable Maxima 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 reusable Maxima Surgical Gown is provided non-sterile. Sterilization parameters are as follows: * Prevac Steam Sterilization - 135 0 C/274 0 F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time) Elevate Textiles Item Numbers / gown color / liquid barrier protection / gown size MAXAL3S / Royal Blue B103 / AAMI Level 3 / Small MAXAL3M / Royal Blue B103 / AAMI Level 3 / Medium MAXAL3L / Royal Blue B103 / AAMI Level 3 / Large

Source page: https://510kreport.com/device/K201351
Methodology: https://510kreport.com/methodology