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510(k) Data Aggregation
K Number
K050181Device Name
MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
Manufacturer
Date Cleared
2005-04-13
(76 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MEDIGLOVES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Device Description
The gloves are made of polyisoprene synthetic latex and green colored. They are washed with Ammonia solution to leach off mold release powder, chemical and protein before they are chlorinated and inner coated with the solution of coating material for ease of donning. The gloves are tested for pinhole by water leak test machine. They are sterilized by gamma irradiation.
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