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Found 4 results
510(k) Data Aggregation
K Number
K162924Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
Manufacturer
Date Cleared
2017-01-24
(98 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDB. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) is as per below table.
Device Description
Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
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K Number
K160928Device Name
Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)
Manufacturer
Date Cleared
2016-12-20
(260 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDB. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim of 50 Microgram or Less per Gram of Glove (Natural) is made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim of 50 Microgram or Less per Gram of Glove (Green) is made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Not Found
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K Number
K142805Device Name
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
Manufacturer
Date Cleared
2014-12-18
(80 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDB. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) 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 with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU)
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K Number
K142270Device Name
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
Manufacturer
Date Cleared
2014-11-25
(102 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDB. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Latex Powdered Examination Glove with Protein Labeling Claim of 200 Microgram or Less Per Gram of 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.
Device Description
Latex Powdered Examination Gloves with Protein Labeling Claim of 200 Microgram or Less Per Gram of Glove
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