# K221637: Surgical Gown (Sterile); Surgical Gown (Non-sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Allmed Medical (Hubei) Protective Products Co., Ltd.
- Decided: Sep 29, 2022 after 115 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: 2 generations back to K192290 (2020). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202706: Surgical Gown (Sterile), Surgical Gown (Non-sterile), B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (2020) Summary page 4.

## Indications for use
The proposed surgical gowns are 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 surgical gowns met the requirements for Level 3 classification. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.

Source page: https://510kreport.com/device/K221637
Methodology: https://510kreport.com/methodology