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510(k) Data Aggregation
K Number
K971666Device Name
SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1997-07-03
(58 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SJ MEDICAL PRODUCTS (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and is intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Smart Fit ; Nitrile Examination Gloves Prepowdered.
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K Number
K971665Device Name
SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1997-06-27
(52 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SJ MEDICAL PRODUCTS (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove is disposable and is intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Smart-Fit; Nitrile Examination Gloves Powderfree.
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K Number
K971403Device Name
SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE
Manufacturer
Date Cleared
1997-05-29
(44 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SJ MEDICAL PRODUCTS (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This glove Is disposable and is intended for medioal purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Smart Glove Latex Patternt Examination Gloves Powderfree, 50 mogm or less water extractable protein.
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