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Found 12 results
510(k) Data Aggregation
K Number
K201531Device Name
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Manufacturer
Hartalega SDN. BHD.
Date Cleared
2020-08-05
(58 days)
Product Code
LZA, LZC, QDO
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 Sterile NItrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a 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 and Fentanyl Citrate. The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
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K Number
K200897Device Name
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
Manufacturer
Hartalega SDN. BHD.
Date Cleared
2020-06-01
(59 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
The Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
The Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
Device Description
Not Found
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K Number
K180786Device Name
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
Manufacturer
HARTALEGA SDN. BHD.
Date Cleared
2018-11-02
(221 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 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)-Extended Cuff is a 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 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU) is a 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.
Device Description
Not Found
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K Number
K173509Device Name
Biodegradable Nitrile Powder Free Examination Glove (Blue)
Manufacturer
Hartalega Sdn. Bhd.
Date Cleared
2018-08-17
(277 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 Biodegradable Nitrile Powder Free Examination Glove (Blue) is a non-sterile disposable device intended for medical purpose that is worn on examinet's hand to prevent contamination between patient and examiner.
Device Description
Biodegradable Nitrile Powder Free Examination Glove (Blue)
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K Number
K180505Device Name
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
Manufacturer
Hartalega Sdn. Bhd.
Date Cleared
2018-06-14
(108 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 Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) 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. Is it 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) 17.2 minutes
Cisplatin (1.0 mg/ml) >240 minutes
Cyclophosphamide (20 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) >240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes
Etoposide (20 mg/ml) > 240 minutes
Fluorouracil (50 mg/ml) > 240 minutes
Methotrexate (25 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxel (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 36.1 minutes
Vincristine Sulfate (1.0 mg/ml) >240 minutes
Do not use with Carmustine. Do not use with Thiotepa.
Device Description
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White)
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K Number
K173137Device Name
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
Manufacturer
Hartalega Sdn. Bhd.
Date Cleared
2017-12-12
(74 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 Glove Tested for Use with Chemotherapy Drugs (Pink) 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. Is it also tested to be used against Chemotherapy Drugs.
Device Description
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
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K Number
K171874Device Name
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
Manufacturer
HARTALEGA SDN. BHD.
Date Cleared
2017-10-12
(111 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 Colloidal Oatmeal USP Skin Protectant and Tested for Use with Chemotherapy Drugs (Dawn 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. It is also tested to be used against Chemotherapy Drugs.
Device Description
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use with Chemotherapy Drugs (Dawn Blue)
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K Number
K162491Device Name
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Manufacturer
HARTALEGA SDN. BHD.
Date Cleared
2017-02-08
(154 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 Low Dermatitis Potential Claim (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 with Low Dermatitis Potential Claim (Blue)
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K Number
K162818Device 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
2017-01-09
(95 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 Potential 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 Dermatitis Potential Claim and Tested for Use with Chemotherapy Druzs (Blue)
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K Number
K162819Device Name
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Manufacturer
HARTALEGA SDN. BHD.
Date Cleared
2017-01-09
(95 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 Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs 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) 10.1 minutes
Cisplatin (1.0 mg/ml) > 240 minutes
Cyclophosphamide (20 mg/ml) > 240 minutes
Dacarbazine (10.0 mg/ml) > 240 minutes
Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes
Etoposide (20.0 mg/ml) > 240 minutes
Fluorouracil (50.0 mg/ml) > 240 minutes
Methotrexate (25 mg/ml) > 240 minutes
Mitomycin C (0.5 mg/ml) > 240 minutes
Paclitaxel (6.0 mg/ml) > 240 minutes
Thiotepa (10.0 mg/ml) 30.4 minutes
Vincristine Sulfate (1.0 mg/ml) > 240 minutes
Please note that Carmustine and Thiotepa have extremely low permeation times of 10.1 minutes.
Device Description
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
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