Non-Woven Compress
FDA 510(k) K980382 · Convatec, A Division of E.R. Squibb & Sons
510(k) numberK980382
Submission
- Device name
- Non-Woven Compress
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
Skillman, NJ, US - Received
- February 2, 1998
- Decision date
- March 9, 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 |
| K974823 | Nonwoven DressingKMF · Traditional | 02/20/1998SN |
| K974205 | Knitted Wound Dressing-Standard, WCL and RibbonKMF · Traditional | 02/06/1998SE |
| K974304 | Germicidal ClothLRJ · Traditional | 01/13/1998SE |
Questions and answers
When was Non-Woven Compress cleared by the FDA?
Non-Woven Compress (K980382) received a 510(k) decision of Substantially Equivalent for Some Indications on March 9, 1998, 35 days after the submission was received.
What is the product code of K980382?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.