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Found 45 results
510(k) Data Aggregation
K Number
K201748Device Name
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
Manufacturer
Hartalega SDN BHD
Date Cleared
2020-10-02
(98 days)
Product Code
KGO, LZC
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Hartalega SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination.
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K Number
K180645Device Name
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
Manufacturer
Hartalega Sdn Bhd
Date Cleared
2018-11-16
(249 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs -(Lemon Green) 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 below:
Carmustine (3.3 mg/ml) 5.4 minutes
Cisplatin (1.0 mg/ml) > 240 minutes
Cyclophosphamide (20.0 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) > 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes
Etoposide (20.0 mg/ml) > 240 minutes
Fluorouracil (50.0 mg/ml) > 240 minutes
Methotrexate (25.0 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxe 1 (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 35.2 minutes
Vincristine Sulfate (1.0 mg/ml) > 240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 5.4 minutes
Device Description
Not Found
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K Number
K180644Device Name
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
Manufacturer
Hartalega Sdn Bhd
Date Cleared
2018-08-10
(151 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hartalega Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal - Lemon Green 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.
Device Description
Nitrile Powder Free Examination Glove with Colloidal Oatmeal - Lemon Green
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K Number
K170152Device Name
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2017-05-05
(108 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polychloroprene Powder Free Surgical Glove (Green) is made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Polychloroprene Powder Free Surgical Glove (Green) is made of synthetic rubber.
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K Number
K160560Device Name
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2016-08-04
(157 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nittile Powder Free Examination Glove with Low Dermatitis Claim and Tested for Use with Chemotherapy Drugs (Blue) is a non- sterile disposable device intended for medical purpose that is worn on 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) as per attached table.
Device Description
Nitrile Powder Free Examination Glove with Low Dernatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
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K Number
K150593Device Name
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2015-06-09
(92 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner
Device Description
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
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K Number
K150103Device Name
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2015-04-23
(93 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.
Device Description
Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs
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K Number
K142588Device Name
Nitrile Powder Free Examination Glove (Blue)
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2014-12-18
(94 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Glove (Blue) 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
Device Description
Nitrile Powder Free Examination Glove (Blue)
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K Number
K140050Device Name
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2014-09-12
(246 days)
Product Code
LZA, LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination betwreen patient and examiner.
The Nittile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) and Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)
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K Number
K133953Device Name
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
Manufacturer
HARTALEGA SDN BHD
Date Cleared
2014-05-28
(156 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove - Lemon Green (Lavender Scent) 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
Not Found
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