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510(k) Data Aggregation
K Number
K981133Device Name
POWDERED NITRILE EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-06-05
(77 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SERVICOM SERVICES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similiar personnel to prevent contamination between healthcare personnel and patient
Device Description
POWDERED NITRILE EXAMINATION GLOVES
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K Number
K980611Device Name
POWDERED LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-04-02
(99 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SERVICOM SERVICES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient. It is a single use disposable gloves.
Device Description
Powdered Latex Examination Gloves
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K Number
K974832Device Name
POWDERFREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1998-02-11
(49 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SERVICOM SERVICES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and patient. It is a single use disposable gloves.
Device Description
Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less)
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