Skin Barrier Film
FDA 510(k) K092712 · Lodestar Products, Inc.
510(k) numberK092712
Submission
- Device name
- Skin Barrier Film
- Applicant
- Lodestar Products, Inc.
Plano, TX, US - Received
- September 3, 2009
- Decision date
- February 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
Other 510(k)s with product code KMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241916 | TearRepair Liquid Skin ProtectantKMF · Traditional | Optmed, Inc. | 09/27/2024SE |
| K182733 | Rochal Bioshield Silicone FilmKMF · Traditional | Rochal Industries, LLC | 06/27/2019SE |
| K171148 | Aleo BME Liquid BandageKMF · Traditional | Aleo Bme, Inc. | 01/12/2018SE |
| K153571 | Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional | 3M Healthcare | 08/23/2016SE |
| K160684 | Atteris No-Sting Skin ProtectantKMF · Traditional | Rochal Industries, LLC | 07/26/2016SE |
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional | Kericure, Inc. | 08/07/2014SE |
| K133443 | Marathon No Sting Liquid Skin ProtectantKMF · Traditional | Advanced Medical Solutions (Plymouth), Ltd. | 07/10/2014SE |
| K120059 | Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 05/17/2012SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
| K083913 | Chesson Labs Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 07/31/2009SE |
Questions and answers
When was Skin Barrier Film cleared by the FDA?
Skin Barrier Film (K092712) received a 510(k) decision of Substantially Equivalent on February 23, 2010, 173 days after the submission was received.
What is the product code of K092712?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.