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510(k) Data Aggregation
K Number
K050071Device Name
MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE
Manufacturer
H.B.M. USA CO.,INC.
Date Cleared
2005-05-11
(119 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
H.B.M. USA CO.,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MEDISPO powdered surgeon's gloves are sterile disposable devices 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.
MEDISPO-PF powder-free surgeon's gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to he worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Device Description
MEDISPO and MEDISPO-PF meet the requirements for surgical gloves described by ASTM D3577.
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