# K241214: ProPel SG3™ Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Standard Textile Co., Inc.
- Decided: Sep 10, 2024 after 133 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 K922753 (1993). 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)
- K922753: Compel XTR, Standard Textile Co., Inc. (1993) Summary page 5.

## Indications for use
ProPel SG3™ Surgical Gown is intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70. The reusable Propel Surgical Gown is provided non-sterile and must be sterilized before use. Sterilization parameters are as follows: Prevacuum Steam Sterilization: 132°C/270°F (temperature)/ 4 minutes (exposure time)/15 minute (dry time) Item Number Gown Size Tag Color Gown Size 7565CC17 Yellow SM 7565CC16 Gold MD 7565CC15 Green LG 7565CC14 Red XL 7565CC13 Orange 2XL 7565CC12 Purple 3XL

Source page: https://510kreport.com/device/K241214
Methodology: https://510kreport.com/methodology