(195 days)
MedTrade Products Skin Protective Barrier Wipe is a liquid intended for use as a film-forming product, that upon application to intact or damaged skin forms a long lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids and adhesive products. It is intended as a primary barrier against irritation from body fluids.
MedTrade Product's Skin Protective Barrier Wipe is a polymeric solution which forms a unique film when applied to the skin. The product is dispersed in a unique non-cytotoxic, water based solution, which dries rapidly. MedTrade Products Skin Protective Barrier Wipe helps to protect intact or damaged skin from irritation from incontinence, digestive juices, wound drainage and adhesives. The film is coloriess, transparent and possesses good oxygen and moisture vapour permeability. MedTrade Products Skin Protective Barrier Wipe Wipes are supplied sterile in single use pouches. Packaging will consist of a single dressing in a paper / poly / foil tri laminate pouch, the pouches will then be placed in to a sales carton, with an Instructions For Use Leaflet.
The provided text is related to a 510(k) premarket notification for a medical device called "MedTrade Products Skin Protective Barrier Wipe." This document establishes the substantial equivalence of the device to legally marketed predicate devices.
However, the provided text does not contain information about acceptance criteria, the detailed study design, or performance metrics that would allow for the completion of the requested table and subsequent sections.
The document primarily focuses on:
- Device Description: What the product is and what it's made of.
- Intended Use/Indications for Use: What the device is meant to do.
- Sterilization Method: How the product is sterilized.
- Biocompatibility Testing: Confirmation that biocompatibility testing was successfully completed.
- Predicates: Identification of substantially equivalent predicate devices (3M No-Sting Barrier Film K955103 & Smith & Nephew No-sting Skin Prep K973228).
- Regulatory Classification: Its classification as a Class I device and the relevant regulation.
- FDA Clearance: The official letter from the FDA granting clearance based on substantial equivalence.
Therefore, it is not possible to generate the requested table and study details from the provided text.
To answer your request, information on acceptance criteria and a detailed study report would be needed, which is typically found in the scientific literature, regulatory submissions (beyond the summary provided here), or internal company documentation.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.