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510(k) Data Aggregation
K Number
K981947Device Name
STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)
Manufacturer
Date Cleared
1999-03-03
(273 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BOSTON MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A SURGEON'S GLOVE IS A DEVICE MADE OF NATURAL OR SYNTHETIC RUBBER INTENDED TO BE WORN BY OPERATING ROOM PERSONNEL TO PROTECT A SURGICAL WOUND FROM CONTAMINATION.
Device Description
SURGEON'S GLOVE, STERILE - TYPE II
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K Number
K960841Device Name
POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
Manufacturer
Date Cleared
1996-08-15
(170 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BOSTON MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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