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Found 5 results
510(k) Data Aggregation
K Number
K053406Device Name
BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
Manufacturer
BARRIERMED GLOVE CO.
Date Cleared
2006-07-05
(210 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BARRIERMED GLOVE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BarrierPlus® Gold Powder-free Synthetic Polyisoprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Not Found
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K Number
K061038Device Name
BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490
Manufacturer
BARRIERMED GLOVE CO.
Date Cleared
2006-06-23
(70 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BARRIERMED GLOVE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
BarrierPlus® Platinum Powder-free Synthetic Polychloroprene Surgical Gloves
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K Number
K052772Device Name
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES
Manufacturer
BARRIERMED GLOVE CO.
Date Cleared
2005-12-20
(78 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BARRIERMED GLOVE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
BarrierPlus® Gold Ortho Powder-free Synthetic Polyisoprene Orthopedic Surgical Glove
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K Number
K052892Device Name
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
Manufacturer
BARRIERMED GLOVE CO.
Date Cleared
2005-11-30
(47 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BARRIERMED GLOVE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synthalon® PC Plus Powder-free Polychloroprene Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Synthalon® PC Plus Powder-free Polychloroprene Examination Glove
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K Number
K990710Device Name
BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES
Manufacturer
BARRIERMED GLOVE CO.
Date Cleared
1999-05-20
(77 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
BARRIERMED GLOVE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens.
Device Description
Synthetic Powder-Free Surgical Gloves
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