# K041541: Compel MLR Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Standard Textile Co., Inc.
- Decided: Mar 16, 2005 after 281 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 K921889 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921889: Compel O and R, Standard Textile Co., Inc. (1993) Summary page 1.

## Indications for use
ComPel MLR 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 MLR Surgical gowns will function and perform as a surgical gown. The ComPel MLR 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/K041541
Methodology: https://510kreport.com/methodology