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Found 19 results
510(k) Data Aggregation
K Number
K003350Device Name
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
2001-04-05
(161 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000952Device Name
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
2000-06-30
(98 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001674Device Name
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
2000-06-30
(29 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001672Device Name
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
2000-06-23
(22 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993756Device Name
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
2000-04-28
(175 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.
Device Description
A powder-free nitrile surgeon's glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hands, usually in surgical setting to provide a barrier against potentially infectious materials and other contaminants.
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K Number
K000828Device Name
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
2000-04-07
(24 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K993201Device Name
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
2000-03-29
(187 days)
Product Code
KGO, FEB
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A sterile power-free latex surgeon's glove is a disposable device intended for medical purpose that is worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Sterile Powder-Free Latex Surgical Gloves
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K Number
K993918Device Name
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
2000-02-10
(84 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
Device Description
Multi-ply Powder-free Latex Examination Gloves with Protein content labeling claim(50ug/g or less total water extratable protein content)
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K Number
K993621Device Name
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
1999-12-29
(64 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intendedror for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
Device Description
Pre-Powdered with USP Absorbable Dusting Powder Latex Examination Glove-Blue Color with Protein Labeling Claims 100mic grams or less)
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K Number
K993093Device Name
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
Manufacturer
PAMITEX INDUSTRIES SDN BHD
Date Cleared
1999-10-29
(43 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PAMITEX INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
Device Description
Powder-free Latex Examination Glove with Labeling Claim of 50 micrograms or less of total water extractable protein per gram.
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