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) → FPX — Strip, Adhesive, Closure, Skin # FPX · Strip, Adhesive, Closure, Skin _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/FPX ## Overview - **Product Code:** FPX - **Device Name:** Strip, Adhesive, Closure, Skin - **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) - **3rd-party reviewable:** yes ## 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 35) Showing 20 most recent of 35 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K970441](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K970441.md) | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | Medi-Flex Hospital Products, Inc. | May 9, 1997 | SESE | | [K952947](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K952947.md) | DELPORE SKIN CLOSURE | Bitco Intl. | Jul 24, 1995 | SESE | | [K952702](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K952702.md) | DERMA SEAL | Ttl Medical | Jun 28, 1995 | SESE | | [K946321](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K946321.md) | BIOSTRIP STERILE WOUND CLOSURE STRIP | Cornelia Damsky, Inc. | Jan 12, 1995 | SESE | | [K931005](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K931005.md) | DUKAL SKIN CLOSURE STRIP | Dukal Corp. | Jul 14, 1993 | SESE | | [K921775](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K921775.md) | SPYROFLEX WOUND CLOSURES | Polymint Industrial Co. , Ltd. | May 19, 1992 | SESE | | [K894802](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K894802.md) | AWC BUTTERFLY WOUND CLOSURES | American White Cross, Inc. | Jan 31, 1990 | SESE | | [K894205](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K894205.md) | TECNOL SILK STRIP | Tecnol New Jersey Wound Care, Inc. | Jul 25, 1989 | SESE | | [K874813](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K874813.md) | OMED WOUND CLOSURE STRIPS | Oxboro Medical Intl., Inc. | Jan 29, 1988 | SESE | | [K840945](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K840945.md) | SKIN CLOSURE | Gainor Medical | Oct 31, 1984 | SESE | | [K842621](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K842621.md) | SUTURE STRIP | Genetic Laboratories, Inc. | Oct 25, 1984 | SESE | | [K833258](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K833258.md) | SKIN TECH. SURGI-STRIPS | Lee Tec Corp. | Jan 25, 1984 | SESE | | [K833083](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K833083.md) | DERMA STRIP-TM SKIN CLOSURES | Howmedica Corp. | Dec 30, 1983 | SESE | | [K831438](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K831438.md) | ELASTOPLAST | Beiersdorf, Inc. | Nov 25, 1983 | SESE | | [K831439](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K831439.md) | ELASTOPLAST T.P.N. | Beiersdorf, Inc. | Sep 29, 1983 | SESE | | [K821763](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K821763.md) | SHUR-STRIP APPLICATOR | Shur Medical Corp. | Jun 23, 1982 | SESE | | [K802385](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K802385.md) | CUSTOM DRESSING TRAY-WET TO DRY/MASS. | American Medical Disposable, Inc. | Nov 12, 1980 | SESE | | [K802384](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K802384.md) | CENTRAL VENOUS CATHETER DRESSING TRAY | American Medical Disposable, Inc. | Nov 12, 1980 | SESE | | [K801837](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K801837.md) | PLASTIC STRIP BANDAGES | Martin'S Maine Exchange | Oct 31, 1980 | SESE | | [K801884](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX/K801884.md) | OP-SITE SKIN CLOSURE SUTURE ADHESIVE | Acme United Corp. | Oct 10, 1980 | SESE | ## Top Applicants - Johnson & Johnson Professionals, Inc. — 7 clearances - Beiersdorf, Inc. — 6 clearances - American Medical Disposable, Inc. — 2 clearances - Shur Medical Corp. — 2 clearances - Abbott Laboratories — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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