Nonwoven Dressing
FDA 510(k) K974823 · Convatec, A Division of E.R. Squibb & Sons
510(k) numberK974823
Submission
- Device name
- Nonwoven Dressing
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
Skillman, NJ, US - Received
- December 24, 1997
- Decision date
- February 20, 1998
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
| K092712 | Skin Barrier FilmKMF · Traditional | Lodestar Products, Inc. | 02/23/2010SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
More from Polichem S.A
| 510(k) | Device | Decision |
|---|---|---|
| K090254 | Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)FRO · Traditional | 09/04/2009SE |
| K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingFRO · Traditional | 05/02/2008SE |
| K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…FRO · Traditional | 04/16/2007SE |
| K013814 | Absorbent Antimicrobial Wound DressingFRO · Traditional | 06/21/2002SE |
| K990964 | Signadress Duoderm DressingKGN · Traditional | 05/18/1999SE |
| K984388 | Ha Absorbent Wound DressingKGN · Traditional | 03/03/1999SE |
| K980720 | Nonwoven PadKMF · Traditional | 04/15/1998SE |
| K980382 | Non-Woven CompressKMF · Traditional | 03/09/1998SN |
| K974205 | Knitted Wound Dressing-Standard, WCL and RibbonKMF · Traditional | 02/06/1998SE |
| K974304 | Germicidal ClothLRJ · Traditional | 01/13/1998SE |
Questions and answers
When was Nonwoven Dressing cleared by the FDA?
Nonwoven Dressing (K974823) received a 510(k) decision of Substantially Equivalent for Some Indications on February 20, 1998, 58 days after the submission was received.
What is the product code of K974823?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.