# K041539: Compel Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Standard Textile Co., Inc.
- Decided: Apr 28, 2005 after 324 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. The FDA summary names no predicate by number.

## Indications for use
ComPel Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown. Surgical gowns may provide different levels of protection dependent upon the fabric materials and/or combinations of fabric materials used and the placement of such materials in the final design of the gown. When processed according to instructions, ComPel Surgical gowns will function and perform as a surgical gown. The ComPel Surgical gowns are reusable through 75 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Source page: https://510kreport.com/device/K041539
Methodology: https://510kreport.com/methodology