# K042111: Promedical Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Promedical Products Co., Ltd.
- Decided: Dec 10, 2004 after 127 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
proMedical Products Co. LTD intends to market Non-sterile surgical gowns identified in 21 CFR 878.4040 as medical devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from the transfer of microorganisms, bodily fluids and particulate material.

Source page: https://510kreport.com/device/K042111
Methodology: https://510kreport.com/methodology