# K102692: SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular, Regular with Guider), Spunlace Gowns (Reinfo

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Jincheng Medical Supplier Manufacture Co.
- Decided: Mar 11, 2011 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: 3 generations back to K030364 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 1.
- K070431: Welmed, Inc. Surgical Gowns, Welmed, Inc. (2007) Summary page 1.

## Indications for use
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/K102692
Methodology: https://510kreport.com/methodology