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510(k) Data Aggregation
K Number
K111923Device Name
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Manufacturer
Date Cleared
2011-11-04
(120 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PT. INTAN HEVEA INDUSTRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Latex Examination Gloves, Non Sterile (contains 50 micrograms/dm² or less of total water extractable protein) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Examination Gloves, Non Sterile (contains The 50 micrograms/dm² or less of total water extractable protein) is Class I Device. These gloves are made of natural rubber latex. The gloves can be used either right or left hand (ambidextrous), Disposable, Single Use and Non Sterile. The Specification of this device meets the requirements of ASTM Standard D 3578 - 05 and FDA 1000ml Water Leak Test.
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