# K012186: Master & Frank Surgical Gowns (Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Master & Frank Ent. Co., Ltd.
- Decided: Dec 7, 2001 after 148 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 K964142 (1997). 1 ancestor in all.
23 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964142: Medline Disposable Surgical Drapes and Gowns, Medline Industries, Inc. (1997) Summary page 1.

## Most influential descendants
- K100971: Atek Surgical Gowns (2010), 21 descendants of its own
- 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

## Indications for use
Master & Frank Surgical Gowns (Sterile) are single use article of surgical apparel that is intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material

Source page: https://510kreport.com/device/K012186
Methodology: https://510kreport.com/methodology