# K182733: Rochal Bioshield Silicone Film

- Pathway: 510(k) (Traditional)
- Applicant: Rochal Industries, LLC
- Decided: Jun 27, 2019 after 272 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002338 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131384: Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage, Kericure, Inc. (2014) Summary page 4.

## Indications for use
Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions. OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.

Source page: https://510kreport.com/device/K182733
Methodology: https://510kreport.com/methodology