# K100971: Atek Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Atek Medical & Textile Co., Ltd.
- Decided: Sep 27, 2010 after 172 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 K964142 (1997). 4 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052550: Imc Surgical Gowns, Intl. Medsurg Connection, Inc. (2005) Summary page 3.
- K012186: Master & Frank Surgical Gowns (Sterile), Master & Frank Ent. Co., Ltd. (2001) Summary page 3.

## Most influential descendants
- K120192: Disposable Surgical Gowns (2012), 20 descendants of its own
- K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (2018), 19 descendants of its own
- 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

## Indications for use
Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material. Gowns provided as sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEIVs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard. The following disposable surgical gown types and model numbers are included in this submission

Source page: https://510kreport.com/device/K100971
Methodology: https://510kreport.com/methodology