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U.S. Department of Health and Human Services

Product Classification

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Device tape and bandage, adhesive, adjustable closing mechanism, otc use
Regulation Description Medical adhesive tape and adhesive bandage.
Definition 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
Physical State An adhesive tape, bandage, or adjustable closing mechanism
Technical Method An adhesive tape, bandage, or adjustable closing mechanism that is applied to minor cuts and lacerations
Target Area Use on superficial minor cuts and lacerations. Excluding use on burn wounds and deeps wounds.
Regulation Medical Specialty General Hospital
Review Panel General & Plastic Surgery
Product CodePYO
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(K) Exempt
Regulation Number 880.5240
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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