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Found 3 results
510(k) Data Aggregation
K Number
K013560Device Name
SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9
Manufacturer
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
Date Cleared
2002-01-16
(82 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. (21CFR 878.4460)
Device Description
sempermed® SUPREME is a sterile powder-free surgeon's glove. It is a disposable device made of natural rubber inside coated with a layer of polyurethane derivatives, and butadiene-based copolymer cross-linked by polyacrylates- free of process, siliconized. This glove is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. Water soluble protein less than 50 ug/dm2
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K Number
K012819Device Name
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
Manufacturer
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
Date Cleared
2001-11-16
(85 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. (21CFR 878.4460)
Device Description
sempermed® DERMA plus is a powdered surgeon's glove and it is a disposable device made of natural rubber inside coated with synthetic latex material 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. The glove is powdered with absorbable dusting powder USP Grade
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K Number
K981096Device Name
SEMPERMED SURGEONS' GLOVES - SUPREME
Manufacturer
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
Date Cleared
1998-10-29
(218 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Latex patient surgeons 'gloves powderfree
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