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510(k) Data Aggregation
K Number
K031368Device Name
POWDERED LATEX SURGEON'S GLOVES
Manufacturer
Date Cleared
2004-06-22
(419 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
CEPHAS MEDICAL PRIVATE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powdered surgeon's glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and it 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
Class I Surgeon's Gloves (Powdered) 79 KGO that meets all the requirements of ASTM D 3577-00. A powdered surgeon's glove is a disposable device made of natural rubber lates that bears powder to facilitate donning and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
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