KOX · Solvent, Adhesive Tape
General, Plastic Surgery · 21 CFR 878.4730 · Class 1
Overview
| Product Code | KOX |
|---|---|
| Device Name | Solvent, Adhesive Tape |
| Regulation | 21 CFR 878.4730 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
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 | SEPP ADHESIVE REMOVER | Medi-Flex Hospital Products, Inc. | Mar 11, 1994 | SESE |
| K931933 | CHAD LABS ADHESIVE BANDAGE REMOVER | Chad Labs Corp. | Jul 8, 1993 | SESE |
| K924976 | ALLKARE(TM) ADHESIVE REMOVER WIPE | Convatec, A Division of E.R. Squibb & Sons | Apr 20, 1993 | SESE |
| K924571 | MEDI-SOL | Orange-Sol, Inc. | Apr 6, 1993 | SESE |
| K925618 | 3M REMOVER LOTION PRODUCT NUMBER 86XX | 3M Health Care, Ltd. | Mar 31, 1993 | SESE |
| K923351 | SKIN SUPPORT PREP PAD | Coloplast Corp. | Sep 14, 1992 | SESE |
| K915150 | REMOVE ADHESIVE REMOVER | Smith & Nephew United, Inc. | Jan 9, 1992 | SESE |
| K902009 | ELANTEC'S SURGICAL TAPE REMOVER | Elantec, Inc. | Aug 29, 1990 | SESE |
| K895293 | KEMI LABS - ADHESIVE BANDAGE REMOVER | Kemi Labs, Inc. | Feb 9, 1990 | SESE |
| K893603 | REMOVE ADHESIVE REMOVER | Smith & Nephew United, Inc. | Jul 14, 1989 | SESE |
| K881359 | DECALCIFYING SOLUTION II | Stephens Scientific | Apr 19, 1988 | SESE |
| K821162 | 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
