# K991667: Broadline or Towels

- Pathway: 510(k) (Traditional)
- Applicant: Broadline Medical Industries
- Decided: Sep 27, 1999 after 136 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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
This device is composed of 100% natural cotton fiber. The intended uses of an operating room towel are the absorption of fluids, including blood and body fluids while being used as patient drape at the incision site, or serving as a general use sterile towel for drying hands. The product is intended for single use and is disposable. This product is not intended to be used as a protective barrier.

Source page: https://510kreport.com/device/K991667
Methodology: https://510kreport.com/methodology