Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5240](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5240) → KGX — Tape And Bandage, Adhesive # KGX · Tape And Bandage, Adhesive _General Hospital · 21 CFR 880.5240 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX ## Overview - **Product Code:** KGX - **Device Name:** Tape And Bandage, Adhesive - **Regulation:** [21 CFR 880.5240](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5240) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) ## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K001240.md) | SERAGARD INJECTION PATCH | Platinum Services, Inc. | Jun 21, 2000 | SESE | | [K983368](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K983368.md) | CARE BAND ANTIBACTERIAL BANDAGES | Aso Corp. | Feb 17, 1999 | SESE | | [K972914](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K972914.md) | SYVEK PATCH | Marine Polymer Technologies, Inc. | Dec 22, 1997 | SESE | | [K943314](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K943314.md) | ADHESIVE BANDAGES WITH OTC DRUG | Johnson & Johnson Consumer Products, Inc. | Jan 17, 1996 | SESE | | [K952606](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K952606.md) | TARGETT PATCH | Cutting Edge Technologies, Inc. | Dec 21, 1995 | SESE | | [K954007](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K954007.md) | PARALLEL | Johnson & Johnson Consumer Products, Inc. | Nov 22, 1995 | SESE | | [K944587](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K944587.md) | DERMIVIEW HYPOALLERGENIC CLEAR TAPE | Johnson & Johnson Medical, Inc. | Oct 30, 1995 | SESE | | [K944588](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K944588.md) | STERILE PLASTIC DRESSING | Smith & Nephew, Inc. | Nov 7, 1994 | SESE | | [K941788](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K941788.md) | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | Johnson & Johnson Consumer Products, Inc. | Oct 3, 1994 | SESE | | [K940536](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K940536.md) | BAND-AID(TM) BRAND ADHESIVE BANDAGE | Johnson & Johnson Consumer Products, Inc. | Oct 3, 1994 | SESE | | [K940798](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K940798.md) | SHIPPERT PRESSURE BANDAGE | Denver Splint Co. | Sep 28, 1994 | SESE | | [K941389](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K941389.md) | EMPI TAPE PATCHES | Empi | Aug 23, 1994 | SESE | | [K942383](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K942383.md) | DERMIVIEW CLEAR TAPE | Johnson & Johnson International | Aug 22, 1994 | SESE | | [K940378](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K940378.md) | COVERLET ADHESIVE DRESSING | Beiersdorf, Inc. | Jul 29, 1994 | SN | | [K941499](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K941499.md) | KIT PAK DRESSING CHANGE TRAY | Kit Pak, Inc. | Jul 20, 1994 | SEKD | | [K941943](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K941943.md) | SURGICAL ADHESIVE TAPE | Raleigh Lions Clinic For the Blind, Inc. | Jun 30, 1994 | SESE | | [K941379](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K941379.md) | ACE SPORTS TAPE | Becton Dickinson Consumer Products | Jun 13, 1994 | SESE | | [K935948](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K935948.md) | CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM | Convatec, A Division of E.R. Squibb & Sons | Mar 1, 1994 | SESE | | [K932457](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K932457.md) | SPYROGEL WOUND DRESSING | Polymint Industrial Co. , Ltd. | Feb 9, 1994 | SN | | [K935725](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX/K935725.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KGX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com