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Found 9 results
510(k) Data Aggregation
K Number
K173304Device Name
Finessis Intense Polyisoprene Surgical Glove
Manufacturer
Date Cleared
2018-04-30
(194 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Lucenxia Prescience Ag
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This surgeon's glove is a device made of polyisoprene rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
This surgeon's glove is a device made of polyisoprene rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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K Number
K173386Device Name
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs
Manufacturer
Date Cleared
2018-04-09
(161 days)
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Lucenxia Prescience AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa.
Device Description
This surgeon's glove is a device made of Flexylon.
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K Number
K171987Device Name
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
Manufacturer
Date Cleared
2017-10-20
(109 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Lucenxia Prescience AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
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K Number
K162852Device Name
Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
Manufacturer
Date Cleared
2017-02-08
(120 days)
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Lucenxia Prescience AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa Chemical Resistance Data per ASTM D 6978-05
Device Description
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.
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K Number
K151605Device Name
Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
Manufacturer
Date Cleared
2015-11-16
(154 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Lucenxia Prescience AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.
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K Number
K151607Device Name
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
Manufacturer
Date Cleared
2015-11-16
(154 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Lucenxia Prescience AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
FINESSIS ZERO Flexylon Powder Free Sterile White Surgical Glove. Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.
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K Number
K131751Device Name
FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
Manufacturer
Date Cleared
2013-09-25
(103 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
LUCENXIA PRESCIENCE AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (21 CFR 878.4460)
Device Description
FINESSIS VIOLET Element Polyisoprene Powderfree Sterile Surgical Gloves
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K Number
K123629Device Name
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
Manufacturer
Date Cleared
2013-05-13
(171 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
LUCENXIA PRESCIENCE AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (21 CFR 878.4460)
Device Description
FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves, FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.
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K Number
K123628Device Name
STERILE LATEX SURGICAL GLOVE
Manufacturer
Date Cleared
2013-03-18
(115 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
LUCENXIA PRESCIENCE AG
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. The lubricating or dusting powder used in the glove is excluded.
Device Description
FINESSIS PERSONAL Latex Powder Free Sterile Surgical Gloves with Protein Claim.
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