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Found 8 results
510(k) Data Aggregation
K Number
K123126Device Name
MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
Manufacturer
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Date Cleared
2014-06-04
(608 days)
Product Code
KGO, CLA
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MOTEX HEALTHCARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of 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
Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.
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K Number
K132802Device Name
MOTEX POWDERED NITRILE SURGICAL GLOVES
Manufacturer
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Date Cleared
2014-05-21
(257 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MOTEX HEALTHCARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Motex Powdered Nitrile Surgical Gloves are sterile disposable devices made of 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
Motex Powdered Nitrile Surgical Gloves are made of synthetic rubber. They are sterilized by radiation, and intended to be used in surgery to prevent the cross contamination between patient and user.
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K Number
K122557Device Name
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
Manufacturer
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Date Cleared
2013-10-03
(407 days)
Product Code
KGO, OCT
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MOTEX HEALTHCARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A surgeon's glove is a sterile and for single use device made of 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
Motex Powder-free Nitrile Surgical Gloves are made of synthetic rubber. Thev are sterilized by radiation, and intended for be used in surgery for patient and user.
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K Number
K063757Device Name
MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES
Manufacturer
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Date Cleared
2007-07-27
(220 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MOTEX HEALTHCARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex 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.
Device Description
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder).
Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning.
The characteristics are summarized below compared to ASTM and ISO standards to the predicate device:
Characteristic: Dimensions, Standard: meets ASTM D 3577-06,
Characteristic: Physical Properties, Standard: meets ASTM D 3577-06,
Characteristic: Freedom from Holes, Standard: meets ASTM D 3577-06,
Characteristic: Biocompatibility, Standard: meets ISO10993-5/-10
Characteristic: Sterilization Validation, Standard: meets ISO11137
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K Number
K041276Device Name
POWDER-FREE NITRILE EXAMINATION GLOVES
Manufacturer
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Date Cleared
2004-08-20
(100 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MOTEX HEALTHCARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This green powder-free nitrile examination glove is a disposable device made of nitrile rubber that may bear trace amount of powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants (21 CFR 880.6250).
Device Description
Nitrile rubber is impermeable to water and body fluids under normal conditions of use. The physical properties of the nitrile rubber enable it to conform to the hand for medical procedures. Nitrile rubber is known to form a superior barrier to bloodborne pathogens and meet physical properties for medical examination procedures as specified in ASTM D6319-00ae3.
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K Number
K030207Device Name
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
Manufacturer
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Date Cleared
2003-05-02
(101 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MOTEX HEALTHCARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder-free Examination Glove, ProBlue is a disposable device made of synthetic materials intended for medical purposes that are worn on the examiner's hand or finger(s) to prevent contamination of potentially infectious materials between patient and examiner.
Device Description
Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735
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K Number
K020837Device Name
MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
Manufacturer
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Date Cleared
2002-12-02
(263 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MOTEX HEALTHCARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Device Description
disposable device made of natural rubber latex material that may bear a trace amount of glove powder
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K Number
K013261Device Name
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
Manufacturer
SHANGHAI MOTEX HEALTHCARE CO., LTD.
Date Cleared
2001-11-29
(59 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MOTEX HEALTHCARE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
Device Description
Nitrile Powder-free Examination Glove is a disposable device made of synthetic materials intended for medical purposes that is worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.
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