Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4730](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4730) → KOX — Solvent, Adhesive Tape

# KOX · Solvent, Adhesive Tape

_General, Plastic Surgery · 21 CFR 878.4730 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX

## Overview

- **Product Code:** KOX
- **Device Name:** Solvent, Adhesive Tape
- **Regulation:** [21 CFR 878.4730](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4730)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K934790](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K934790.md) | SEPP ADHESIVE REMOVER | Medi-Flex Hospital Products, Inc. | Mar 11, 1994 | SESE |
| [K931933](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K931933.md) | CHAD LABS ADHESIVE BANDAGE REMOVER | Chad Labs Corp. | Jul 8, 1993 | SESE |
| [K924976](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K924976.md) | ALLKARE(TM) ADHESIVE REMOVER WIPE | Convatec, A Division of E.R. Squibb & Sons | Apr 20, 1993 | SESE |
| [K924571](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K924571.md) | MEDI-SOL | Orange-Sol, Inc. | Apr 6, 1993 | SESE |
| [K925618](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K925618.md) | 3M REMOVER LOTION PRODUCT NUMBER 86XX | 3M Health Care, Ltd. | Mar 31, 1993 | SESE |
| [K923351](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K923351.md) | SKIN SUPPORT PREP PAD | Coloplast Corp. | Sep 14, 1992 | SESE |
| [K915150](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K915150.md) | REMOVE ADHESIVE REMOVER | Smith & Nephew United, Inc. | Jan 9, 1992 | SESE |
| [K902009](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K902009.md) | ELANTEC'S SURGICAL TAPE REMOVER | Elantec, Inc. | Aug 29, 1990 | SESE |
| [K895293](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K895293.md) | KEMI LABS - ADHESIVE BANDAGE REMOVER | Kemi Labs, Inc. | Feb 9, 1990 | SESE |
| [K893603](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K893603.md) | REMOVE ADHESIVE REMOVER | Smith & Nephew United, Inc. | Jul 14, 1989 | SESE |
| [K881359](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K881359.md) | DECALCIFYING SOLUTION II | Stephens Scientific | Apr 19, 1988 | SESE |
| [K821162](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX/K821162.md) | ADHESIVE REMOVER | The Healthcare Group Laboratories, Inc. | May 14, 1982 | SESE |

## Top Applicants

- Smith & Nephew United, Inc. — 2 clearances
- 3M Health Care, Ltd. — 1 clearance
- Chad Labs Corp. — 1 clearance
- Coloplast Corp. — 1 clearance
- Convatec, A Division of E.R. Squibb & Sons — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KOX)

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