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510(k) Data Aggregation
K Number
K990677Device Name
ABSOGEL CHEMOTHERAPHY GLOVES
Manufacturer
Date Cleared
1999-11-01
(244 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
AMPRI RUBBERWARE INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove 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. The extra thickness of this glove is suitable for use in an environment of higher risks, such as Paramedics, Emergency Room, etc. This glove may also provide additional protection in other areas where users are handling certain hazardous chemicals such as chemotherapy drugs, as penetration and permeation to these chemicals are prevented.
Device Description
Absogel Powder Free Latex Examination Gloves with Protein Content (50 micrograms or less) and Chemotherapy Drug Protection Claims
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K Number
K990812Device Name
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA
Manufacturer
Date Cleared
1999-05-04
(54 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
AMPRI RUBBERWARE INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Powder-Free Latex Examination Gloves
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K Number
K954002Device Name
AMPRI
Manufacturer
Date Cleared
1996-01-29
(157 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
AMPRI RUBBERWARE INDUSTRIES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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