# K140389: Chloraderm Antimicrobial Transparent Thin Film Dressing, 2 3/8 X 2 3/4, 4 X 4 3/4

- Pathway: 510(k) (Traditional)
- Applicant: Entrotech Life Sciences, Inc.
- Decided: Nov 7, 2014 after 266 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K895920 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121819: Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver, Covalontechnologies, Inc. (2012) Summary page 5.
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres, 3M Healthcare (1997) Summary page 5.

## Indications for use
The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings are intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures and wires. ChloraDerm™ may also be used to cover and secure primary dressings. ChloraDerm™ inhibits microbial growth within the dressing and prevents external contamination.

Source page: https://510kreport.com/device/K140389
Methodology: https://510kreport.com/methodology