Solvent, Adhesive Tape
FDA product code KOX · Class I (low risk) · 21 CFR 878.4730 · General, Plastic Surgery
12510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934790 | Sepp Adhesive RemoverKOX · Traditional | Medi-Flex Hospital Products, Inc. | 03/11/1994SE |
| K931933 | Chad Labs Adhesive Bandage RemoverKOX · Traditional | Chad Labs Corp. | 07/08/1993SE |
| K924976 | Allkare(Tm) Adhesive Remover WipeKOX · Traditional | Convatec, A Division of E.R. Squibb & Sons | 04/20/1993SE |
| K924571 | Medi-SolKOX · Traditional | Orange-Sol, Inc. | 04/06/1993SE |
| K925618 | 3M Remover Lotion Product Number 86XXKOX · Traditional | 3M Health Care, Ltd. | 03/31/1993SE |
| K923351 | Skin Support Prep PadKOX · Traditional | Coloplast Corp. | 09/14/1992SE |
| K915150 | Remove Adhesive RemoverKOX · Traditional | Smith & Nephew United, Inc. | 01/09/1992SE |
| K902009 | Elantec's Surgical Tape RemoverKOX · Traditional | Elantec, Inc. | 08/29/1990SE |
| K895293 | Kemi Labs - Adhesive Bandage RemoverKOX · Traditional | Kemi Labs, Inc. | 02/09/1990SE |
| K893603 | Remove Adhesive RemoverKOX · Traditional | Smith & Nephew United, Inc. | 07/14/1989SE |
| K881359 | Decalcifying Solution IIKOX · Traditional | Stephens Scientific | 04/19/1988SE |
| K821162 | Adhesive RemoverKOX · Traditional | The Healthcare Group Laboratories, Inc. | 05/14/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2751-2011 | Brand REMOVE Universal Adhesive Remover Wipe - Pouch Label and 50 count box Label:…Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE… | Smith & Nephew Inc. | 04/04/2011Terminated |
| Z-2750-2011 | Brand: UNI-SOLVE Adhesive Remover Wipe Pouch, 50 Count Box Label…Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE… | Smith & Nephew Inc. | 04/04/2011Terminated |
| Z-0413-2011 | Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a…There is a defect on the neck surface of the bottles, causing bottles to leak. Bottle defect may potentially… | Ferndale Laboratories, Inc. | 07/07/2010Terminated |