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Found 7 results
510(k) Data Aggregation
K Number
K062526Device Name
BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
Manufacturer
Date Cleared
2007-04-13
(228 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MULTISAFE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Blue Powdered Latex Examination Gloves, Non-sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as barrier against potentially infectious materials and other contamination.
Device Description
Latex Patient Examination Gloves, LYY, Powdered
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K Number
K062527Device Name
BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
Manufacturer
Date Cleared
2007-02-20
(176 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MULTISAFE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Blue Powder Free Latex Examination Gloves, Non-Sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as a barrier against potentially infectious materials and other contamination.
Device Description
Latex Patient Examination Gloves, LYY, Powder Free
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K Number
K011293Device Name
POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
Manufacturer
Date Cleared
2001-07-10
(71 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MULTISAFE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001497Device Name
MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
Manufacturer
Date Cleared
2000-07-26
(72 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MULTISAFE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K001619Device Name
MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
Manufacturer
Date Cleared
2000-07-26
(62 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MULTISAFE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K000999Device Name
MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2000-05-22
(55 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MULTISAFE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993811Device Name
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
Manufacturer
Date Cleared
2000-03-02
(113 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MULTISAFE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powdered patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning 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.
Device Description
Powdered Latex Examination Gloves, Non-sterile
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