# K052550: Imc Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Medsurg Connection, Inc.
- Decided: Nov 17, 2005 after 62 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 K030364 (2003). 1 ancestor in all.
25 later devices descend from it; 3 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)
- K030364: Deroyal Gowns, Sterile, Non-Sterile, Deroyal Industries, Inc. (2003) 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
This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids and particulate matter. This submission includes Surgical Gowns that will be sold both sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

Source page: https://510kreport.com/device/K052550
Methodology: https://510kreport.com/methodology