# K203548: EndoArmor™ + Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Feb 21, 2022 after 444 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: 3 generations back to K020593 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190950: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced), Medline Industries, Inc. (2019) Summary page 4.

## Indications for use
EndoArmor™+ Surgical Gowns are single-use personal protective equipment intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. EndoArmor™+ Surgical Gowns meet the respective Level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

Source page: https://510kreport.com/device/K203548
Methodology: https://510kreport.com/methodology