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510(k) Data Aggregation
K Number
K992128Device Name
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
Manufacturer
Date Cleared
1999-09-14
(83 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
DASH MEDICAL GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Dash Siliconized Polymer Coated Powder Free Latex Examination Gloves with Protein Content Labeling Claim (50 micrograms or Less); VitalGard Siliconized Polymer Coated Powder Free Latex Examination Gloves
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K Number
K974114Device Name
DASH, VITAL GARD
Manufacturer
Date Cleared
1997-12-18
(48 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
DASH MEDICAL GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Not Found
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K Number
K955425Device Name
DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM
Manufacturer
Date Cleared
1996-12-30
(398 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
DASH MEDICAL GLOVES SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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