# K070431: Welmed, Inc. Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Welmed, Inc.
- Decided: May 24, 2007 after 100 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 K030364 (2003). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 2.

## Most influential descendants
- K102692: SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo (2011), 0 descendants of its own
- K082479: Sklar Surgical Gown (2009), 0 descendants of its own

## Indications for use
Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates. Gowns provided as 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/K070431
Methodology: https://510kreport.com/methodology