# K013958: Indus Textiles Towel-Sterile and Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Indus Textiles, Inc.
- Decided: Aug 19, 2002 after 262 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. The FDA summary names its predicate without a number.
- (no number) Broadline O.R. Towels: named in the summary without a submission number
- (no number) A Plus International O.R. Towel: named in the summary without a submission number
- (no number) Com-Med O.R. Towel: named in the summary without a submission number

## Indications for use
This is a single use disposable surgical towel intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The O.R. towel is also to be used for the absorption of fluids, including blood and body fluids or as a general use towel for drying hands.

Source page: https://510kreport.com/device/K013958
Methodology: https://510kreport.com/methodology