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Found 7 results
510(k) Data Aggregation
K Number
K053441Device Name
BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
Manufacturer
REGENT MEDICAL AMERICAS, LLC
Date Cleared
2006-04-10
(122 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
REGENT MEDICAL AMERICAS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that 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
Biogel Latex Sterile Powder-Free Surgeon's Glove with Low Dermatitis Potential and Protein Content Labeling Claim (50 micrograms or less)
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K Number
K053102Device Name
BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
Manufacturer
REGENT MEDICAL AMERICAS, LLC
Date Cleared
2006-03-10
(126 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
REGENT MEDICAL AMERICAS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of Non-latex that 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
Non-latex sterile powder-free surgeon's glove
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K Number
K053442Device Name
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
Manufacturer
REGENT MEDICAL AMERICAS, LLC
Date Cleared
2006-03-07
(88 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
REGENT MEDICAL AMERICAS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that 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
Poly-Isoprene non-latex sterile powder-free surgeon's glove with Non-pyrogenic statement
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K Number
K053443Device Name
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
Manufacturer
REGENT MEDICAL AMERICAS, LLC
Date Cleared
2006-02-01
(54 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
REGENT MEDICAL AMERICAS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of de-proteinised latex that 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
Eclipse, Non-pyrogenic, latex, powder free, sterile surgeon's glove
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K Number
K050899Device Name
BIOGEL LATEX STERILE POWDER-FREE GLOVE
Manufacturer
REGENT MEDICAL AMERICAS, LLC
Date Cleared
2005-08-12
(123 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
REGENT MEDICAL AMERICAS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that 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
A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that 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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K Number
K050533Device Name
ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
Manufacturer
REGENT MEDICAL AMERICAS, LLC
Date Cleared
2005-04-26
(55 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
REGENT MEDICAL AMERICAS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.
Device Description
A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.
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K Number
K050184Device Name
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
Manufacturer
REGENT MEDICAL AMERICAS, LLC
Date Cleared
2005-03-16
(48 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
REGENT MEDICAL AMERICAS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that 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
A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Ask a Question
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