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510(k) Data Aggregation
K Number
K030444Device Name
PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES
Manufacturer
Date Cleared
2003-06-05
(114 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
PRIMUS GLOVES PRIVATE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K030445Device Name
POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM
Manufacturer
Date Cleared
2003-06-05
(114 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
PRIMUS GLOVES PRIVATE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Surgeons glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
POWDERFREE LATEX MICROSURGERY GLOVES BROWN COLOR
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K Number
K021065Device Name
PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
Manufacturer
Date Cleared
2002-05-08
(36 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
PRIMUS GLOVES PRIVATE LTD.
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
Pre-Powdered Sterile Latex Surgeon's Gloves (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram)
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K Number
K020044Device Name
VINYL EXAMINATION GLOVES STERILE POWEDERED
Manufacturer
Date Cleared
2002-02-26
(50 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PRIMUS GLOVES PRIVATE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Device Description
A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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