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Found 7 results
510(k) Data Aggregation
K Number
K011791Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
Manufacturer
LATEXX PARTNERS BHD.
Date Cleared
2001-08-01
(54 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX PARTNERS BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Nitrile Examination Glove, Violet Color is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Device Description
Powder Free Nitrile Examination Gloves, Violet Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6913-00a Standard Specification for Nitrile Examination Gloves. They are violet in colour and are powder free.
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K Number
K011792Device Name
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
Manufacturer
LATEXX PARTNERS BHD.
Date Cleared
2001-08-01
(54 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX PARTNERS BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powder Free Nitrile Examination Glove, Blue Color is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Device Description
Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Gloves, Blue Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are blue in colour and are powder free.
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K Number
K992924Device Name
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
Manufacturer
LATEXX PARTNERS BHD.
Date Cleared
1999-11-05
(67 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX PARTNERS BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QTEXX, Non - Chlorinated Powder free Nitrile Examination Glove, polymer-coated is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Device Description
QTEXX, Non - Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 – 99, Standard Specification for Rubber Examination Gloves, They are blue or natural white in colour and are powder free.
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K Number
K992671Device Name
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
Manufacturer
LATEXX PARTNERS BHD.
Date Cleared
1999-09-24
(45 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX PARTNERS BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QTEXX Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Device Description
QTEXX Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are blue or natural white in colour.
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K Number
K991462Device Name
QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
Manufacturer
LATEXX PARTNERS BHD.
Date Cleared
1999-05-28
(31 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX PARTNERS BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QTEXX Powder free Latex Examination Glove, polymer-coated is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Device Description
QTEXX Powder Free Latex Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves, They are natural white in colour and are powder free.
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K Number
K981767Device Name
QTEXX POWDERFREE LATEX EXAMINATION GLOVES
Manufacturer
LATEXX PARTNERS BHD.
Date Cleared
1998-06-11
(23 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX PARTNERS BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QTEXX Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Device Description
QTEXX Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.
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K Number
K981159Device Name
PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
Manufacturer
LATEXX PARTNERS BHD.
Date Cleared
1998-06-01
(62 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
LATEXX PARTNERS BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proflex Powderfree Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Device Description
PROFLEX* Powder Free Nitrile Examination Gloves meet the current draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves, EXCEPT for tensile strength and ultimate elongation requirement. They are blue or natural white in colour and are powder free.
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