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510(k) Data Aggregation
K Number
K022095Device Name
DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE
Manufacturer
Date Cleared
2002-08-09
(43 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WILSHIRE TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DuraCLEAN® with LYCRA® Medical Examination Glove is a disposable device made of synthetic LYCRA® polymer that is intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants.
Device Description
The subject device is an ambidextrous, powder-free patient examination glove composed of 100% DuPont LYCRA® polymer. It is offered non-sterile, in a range of sizes from Extra Small to Extra Large.
The device meets the requirements of applicable recognized standards, including those specified by ASTM D3578, ASTM D6124, ASTM D5151, and the agency's June, 1999 draft Medical Glove Guidance Mamual.
The device has been demonstrated biocompatible through dermal irritation, dermal sensitization, and cytotoxicity testing in accordance with EN ISO 10993.
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