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510(k) Data Aggregation
K Number
K984039Device Name
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS)
Manufacturer
Date Cleared
1999-03-29
(137 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CRANBERRY (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is a powder free patient examination glove with 50 Micrograms or less of latex protein. It is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Examination Gloves with Protein Labelling Claim (50 Micrograms or Less)
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K Number
K983334Device Name
NITRILE POWDER FREE EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-02-19
(149 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CRANBERRY (M) SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is a patient examination glove. It is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Nitrile Powder Free Examination Glove - Cranberry
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