# K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)

- Pathway: 510(k) (Traditional)
- Applicant: Gmax Industries, Inc.
- Decided: Jul 13, 2018 after 289 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: 4 generations back to K964142 (1997). 7 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043585: Medline Surgical Gowns, Medline Industries, Inc. (2005) Summary page 7.
- K120192: Disposable Surgical Gowns, Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (2012) Summary page 7.

## Most influential descendants
- K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (2021), 11 descendants of its own
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants of its own
- K212861: Surgical Gown, Reinforced Surgical Gown (2021), 2 descendants of its own
- K202844: Medical Surgical Gowns (2021), 2 descendants of its own
- K231510: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) (2023), 1 descendant of its own

## Indications for use
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification. Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AG series surgical gowns met the requirements for Level 3 classification.

Source page: https://510kreport.com/device/K172987
Methodology: https://510kreport.com/methodology