# K094016: Next Generation Infused (R) or Towel (Hemed), Next Generation Infused (R) or Towel (with Binding) Model HUCKCR17X27MH, H

- Pathway: 510(k) (Traditional)
- Applicant: Hinson and Hale Medical Technologies, Inc.
- Decided: Nov 19, 2010 after 325 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
The Hinson and Hale Medical Technologies, Inc. Next Generation "Infused®" OR Towels, made of synthetic material, both hemmed (Model Number HUCKCR17X27MH) and with binding (Model Number HUCKCR I7X27WB), are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The OR towels are further used as a fluid absorbing towel during surgery or as a device to dry the hands of OR personnel. These towels are provided non-sterile and must be processed before use. These towels may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum sterilizer, 2700 F, 4 minutes with 20 minutes drying time).

Source page: https://510kreport.com/device/K094016
Methodology: https://510kreport.com/methodology