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510(k) Data Aggregation
K Number
K955872Device Name
VOLMED OPERATION DRAPE
Manufacturer
Date Cleared
1996-03-12
(75 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
MEDAL INTL. SALES CO., LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
As a protective patient covering during surgical procedures, such as to isolate a site of surgical incision from microbial and other contamination.
Device Description
The Volmed Operation Drape is a sterile incise drape composed of a transparent mat polyurethane film coated on one side with an acrylic medical grade adhesive, supported by peelable white, silicon coated, double sided polyethylene protected release paper. The other side of the polyurethane film is protected by a polyethylene film which is removed after application of the drape to the surqical site.
Volmed Operations Drapes are supplied in 10 cm x 10 cm x 20 cm, 20 cm x 20 cm, 20 cm x 40 cm and 30 cm x 60 cm sizes in individual packages sterilized by gamma irradiation.
The biocompatibility of the device has been established by in vitro cytotoxicity, subcutaneous implantation (guinea pig), and dermal irritation (rabbit) tests. A repeat insult patch test in human volunteers showed that the material does not induce irritation or allergic contact dermatitis. In addition, a microbial permeability study with S. aureus was performed to demonstrate the effective performance of the drape as a bacterial barrier.
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