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510(k) Data Aggregation
K Number
K221718Device Name
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
Manufacturer
Hartalega NGC SDN BHD
Date Cleared
2022-09-24
(103 days)
Product Code
KGO, LZC
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Hartalega NGC SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---------------------------------------|------------------------------------------------|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Device Description
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.
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K Number
K151997Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
Manufacturer
HARTALEGA NGC SDN BHD
Date Cleared
2016-03-31
(255 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA NGC SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile 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 Gloves Tested for Use with Chemotherapy Drugs -Violet Blue (VBLU)
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K Number
K151836Device Name
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
Manufacturer
HARTALEGA NGC SDN BHD
Date Cleared
2015-10-21
(107 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA NGC SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Gloves is a non - sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Device Description
Not Found
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K Number
K151343Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
Manufacturer
HARTALEGA NGC SDN BHD
Date Cleared
2015-08-24
(97 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA NGC SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs.
Device Description
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White)
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