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Found 3 results
510(k) Data Aggregation
K Number
K983614Device Name
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
Manufacturer
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
Date Cleared
1999-02-04
(113 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
UNISEAL Powder Free Latex Examination Gloves (BLUE + GREEN)
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K Number
K981979Device Name
UNISEAL GLOVES LOW PROTEIN POWDERED
Manufacturer
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
Date Cleared
1998-11-30
(178 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
Uniseal Powdered Latex Examination Glove with Protein Content Labeling Claim (100 micrograms or less)
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K Number
K982218Device Name
NITRILE POWDER-FREE UNISEAL GLOVES
Manufacturer
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
Date Cleared
1998-11-30
(159 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN HEALTHCARE PRODUCTS (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
UNISEAL POWDER-FREE NITRILE EXAMINATION GLOVES
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