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510(k) Data Aggregation
K Number
K023715Device Name
STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
Manufacturer
Date Cleared
2003-02-04
(91 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
STARMATRIX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Examination Gloves, with Protein Labeling Claim. Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram, Natural Color
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K Number
K023977Device Name
PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
Manufacturer
Date Cleared
2003-01-24
(53 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
STARMATRIX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURP THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Pre-Powdered Latex Examination Gloves White Color with Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove
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K Number
K023978Device Name
NITRILE EXAMINATION GLOVES, POWDER FREE
Manufacturer
Date Cleared
2003-01-24
(53 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
STARMATRIX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Nitrile Examination Gloves, Powder Free, Blue Glove
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K Number
K023979Device Name
NITRILE EXAMINATION GLOVES, PRE-POWDERED
Manufacturer
Date Cleared
2003-01-24
(53 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
STARMATRIX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Device Description
Nitrile Examination Gloves, Pre-Powdered, Blue Glove
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