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510(k) Data Aggregation
K Number
K063202Device Name
PRODERMA LIQUID BANDAGE
Manufacturer
PROCUREMENT TECHNOLOGY SYSTEMS, LLC
Date Cleared
2007-05-02
(194 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
PROCUREMENT TECHNOLOGY SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProDerma Liquid Bandage is indicated for over-the-counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.
Device Description
ProDerma Liquid Bandage, a formulated Cyanoacrylate adhesive, is a violet tinted, clear liquid topical bandage composed of 2-Octyl and N-Butyl Cyanoacrylate monomers, a plasticizer and D&C violet #2 pigment.
ProDerma is packaged in a single use applicator containing up to 0.5 grams of product. The single use applicator is constructed in the shape of “tear drop” with the flat bottom side made of a flexible laminated film of Pet/AL/Nitrile and a flexible laminate of either Nitrile/PE or Nitrile/PP/PE formed as a blister on the top side with a polyurethane foam sponge for applying the liquid bandage. Each applicator is individually packaged in a blister with a Tyvek backing. The applicators are packaged in a box with a quantity ranging of 6 to 24 per box depending on the customer's requirements. The applicator is opened by folding over the packet at the narrow end under the foam sponge onto itself. The liquid flows into the foam sponge and is control by the user as pressure is applied to the applicator. ProDerma is then applied to the area in need.
Applicators sterilized to a Sterilization Acceptance Level (SAL) of 10° via commercially available irradiation facilities.
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