Atteris No-Sting Skin Protectant
FDA 510(k) K160684 · Rochal Industries, LLC
510(k) numberK160684
Submission
- Device name
- Atteris No-Sting Skin Protectant
- Applicant
- Rochal Industries, LLC
San Antonio, TX, US - Received
- March 11, 2016
- Decision date
- July 26, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K092712 | Skin Barrier FilmKMF · Traditional | Lodestar Products, Inc. | 02/23/2010SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
| K083913 | Chesson Labs Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 07/31/2009SE |
More from Chesson Laboratory Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192527 | Rochal Antimicrobial Wound GelFRO · Traditional | 02/07/2020SE |
| K182733 | Rochal Bioshield Silicone FilmKMF · Traditional | 06/27/2019SE |
| K161212 | Atteris Antimicrobial Skin ProtectantFRO · Traditional | 09/30/2016SE |
| K160192 | Atteris Antimicrobial Skin & Wound CleanserFRO · Traditional | 07/28/2016SE |
Questions and answers
When was Atteris No-Sting Skin Protectant cleared by the FDA?
Atteris No-Sting Skin Protectant (K160684) received a 510(k) decision of Substantially Equivalent on July 26, 2016, 137 days after the submission was received.
What is the product code of K160684?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.