KGX · Tape And Bandage, Adhesive
General Hospital · 21 CFR 880.5240 · Class 1
Overview
| Product Code | KGX |
|---|---|
| Device Name | Tape And Bandage, Adhesive |
| Regulation | 21 CFR 880.5240 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
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 § 880.9.
Recent Cleared Devices (20 of 187)
Showing 20 most recent of 187 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001240 | SERAGARD INJECTION PATCH | Platinum Services, Inc. | Jun 21, 2000 | SESE |
| K983368 | CARE BAND ANTIBACTERIAL BANDAGES | Aso Corp. | Feb 17, 1999 | SESE |
| K972914 | SYVEK PATCH | Marine Polymer Technologies, Inc. | Dec 22, 1997 | SESE |
| K943314 | ADHESIVE BANDAGES WITH OTC DRUG | Johnson & Johnson Consumer Products, Inc. | Jan 17, 1996 | SESE |
| K952606 | TARGETT PATCH | Cutting Edge Technologies, Inc. | Dec 21, 1995 | SESE |
| K954007 | PARALLEL | Johnson & Johnson Consumer Products, Inc. | Nov 22, 1995 | SESE |
| K944587 | DERMIVIEW HYPOALLERGENIC CLEAR TAPE | Johnson & Johnson Medical, Inc. | Oct 30, 1995 | SESE |
| K944588 | STERILE PLASTIC DRESSING | Smith & Nephew, Inc. | Nov 7, 1994 | SESE |
| K941788 | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | Johnson & Johnson Consumer Products, Inc. | Oct 3, 1994 | SESE |
| K940536 | BAND-AID(TM) BRAND ADHESIVE BANDAGE | Johnson & Johnson Consumer Products, Inc. | Oct 3, 1994 | SESE |
| K940798 | SHIPPERT PRESSURE BANDAGE | Denver Splint Co. | Sep 28, 1994 | SESE |
| K941389 | EMPI TAPE PATCHES | Empi | Aug 23, 1994 | SESE |
| K942383 | DERMIVIEW CLEAR TAPE | Johnson & Johnson International | Aug 22, 1994 | SESE |
| K940378 | COVERLET ADHESIVE DRESSING | Beiersdorf, Inc. | Jul 29, 1994 | SN |
| K941499 | KIT PAK DRESSING CHANGE TRAY | Kit Pak, Inc. | Jul 20, 1994 | SEKD |
| K941943 | SURGICAL ADHESIVE TAPE | Raleigh Lions Clinic For the Blind, Inc. | Jun 30, 1994 | SESE |
| K941379 | ACE SPORTS TAPE | Becton Dickinson Consumer Products | Jun 13, 1994 | SESE |
| K935948 | CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM | Convatec, A Division of E.R. Squibb & Sons | Mar 1, 1994 | SESE |
| K932457 | SPYROGEL WOUND DRESSING | Polymint Industrial Co. , Ltd. | Feb 9, 1994 | SN |
| K935725 | EPISEAL ADHESIVE WOUND CLOSURE STRIPS | Deroyal Industries, Inc. | Feb 4, 1994 | SESE |
Top Applicants
- Beiersdorf, Inc. — 15 clearances
- Lectec Corp. — 8 clearances
- 3M Company — 6 clearances
- Avery Intl. — 6 clearances
- Convatec, A Division of E.R. Squibb & Sons — 6 clearances
