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510(k) Data Aggregation
K Number
K172864Device Name
Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Manufacturer
Maxter Glove Manufacturing Sdn Bhd
Date Cleared
2018-05-02
(224 days)
Product Code
LZC, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Maxter Glove Manufacturing Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Device Description
These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
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K Number
K151390Device Name
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
Manufacturer
MAXTER GLOVE MANUFACTURING SDN BHD
Date Cleared
2016-05-02
(342 days)
Product Code
LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MAXTER GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free patient examination 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes)
------------------------------------------|-----------------------------------------------
Cisplatin, 1.0mg/ml | >240
Cyclophosphamide (Cytoxan), 20mg/ml | >240
Carmustine (BCNU), 3.3mg/ml | 1.0
Dacarbazine (DTIC), 10.0mg/ml | >240
Doxorubicin Hydrochloride, 2.0mg/ml | >240
Etoposide (Toposar), 20.0mg/ml | >240
Fluorouracil, 50.0mg/ml | >240
Paclitaxel (Taxol), 6.0mg/ml | >240
Thiotepa, 10.0mg/ml | 31.3
Methotrexate ,25mg/ml | >240
Mitomycin C, 0.5mg/ml | >240
Vincristine Sulfate, 1.0mg/ml | >240
Ifosfamide, 50.0mg/ml | >240
Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml: 1.0 minute Thiotepa, 10.0mg/ml: 31.3 minutes
Device Description
These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.
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K Number
K113100Device Name
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Manufacturer
MAXTER GLOVE MANUFACTURING SDN BHD
Date Cleared
2012-02-06
(110 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MAXTER GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder free patient examination 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes)
-----------------------------------------|---------------------------------------------
Cisplatin, 1.0mg/ml (1,000ppm) | >240
Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240
Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 0.53
Dacarbazine (DTIC), 10.0mg/ml (10,000ppm)| >240
Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240
Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240
Fluorouracil, 50.0mg/ml (50,000ppm) | >240
Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240
Thiotepa, 10.0mg/ml (10,000ppm) | 75.54
Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
Device Description
Not Found
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K Number
K040176Device Name
MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES
Manufacturer
MAXTER GLOVE MANUFACTURING SDN BHD
Date Cleared
2004-02-24
(29 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MAXTER GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical examination 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
K032501Device Name
MAXTER STERILE POWDER FREE SURGICAL GLOVES
Manufacturer
MAXTER GLOVE MANUFACTURING SDN BHD
Date Cleared
2003-10-17
(65 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MAXTER GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Sterile Powder Free Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Sterile Powder Free Latex Surgical Gloves
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K Number
K032467Device Name
MAXTER STERILE POWDERED LATEX SURGICAL GLOVES
Manufacturer
MAXTER GLOVE MANUFACTURING SDN BHD
Date Cleared
2003-10-10
(60 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MAXTER GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Sterile Powdered Latex Surgical Glove is a disposable device made of natural rubber latex and is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Sterile Powdered Latex Surgical Gloves
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K Number
K013498Device Name
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
MAXTER GLOVE MANUFACTURING SDN BHD
Date Cleared
2002-01-17
(87 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MAXTER GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Chlorinated Powder Free Latex Medical Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein per gram.
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K Number
K013554Device Name
POLYMER COATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
MAXTER GLOVE MANUFACTURING SDN BHD
Date Cleared
2002-01-17
(84 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MAXTER GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Polymer Coated Powder Free Latex Medical Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein per g.
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K Number
K013443Device Name
POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2
Manufacturer
MAXTER GLOVE MANUFACTURING SDN BHD
Date Cleared
2001-11-29
(43 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
MAXTER GLOVE MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
Powdered Latex Medical Examination Gloves with 150 Micrograms or Less of Total Water Extractable Protein per Gram of Glove.
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