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510(k) Data Aggregation
K Number
K121592Device Name
POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
Manufacturer
Date Cleared
2013-01-18
(232 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free nitrile 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.
The tested chemotherapy drugs and their breakthrough detection time are as follows :
| Chemotherapy Drugs & concentration | Average Breakthrough Detection Time |
|----------------------------------------|-------------------------------------|
| Carmustine (BCNU), 3300ppm | 60.2 |
| Cisplatin, 1000ppm | > 240 min |
| Cyclophosphamide (Cytoxan), 20,000 ppm | > 240 min |
| Dacarbazine (DTIC), 10,000 ppm | > 240 min |
| Doxorubicin Hydrochloride, 2000 ppm | > 240 min |
| Etoposide (Toposar), 20,000 ppm | > 240 min |
| Fluorouracil, 50,000 ppm | > 240 min |
| Ifosfamide, 50,000 ppm | > 240 min |
| Methotrexate, 25,000 ppm | > 240 min |
| Mitomycin C, 500 ppm | > 240 min |
| Mitoxantrone, 2000 ppm | > 240 min |
| Paclitaxel (Taxol), 6000 ppm | > 240 min |
| Thiothepa, 10,000 ppm | 105.6 |
| Vincristine Sulfate, 1000 ppm | > 240 min |
Please note that the following drugs have low permeation times: Carmustine - 60.2 minutes Thiothepa - 105.6 minutes
Device Description
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K Number
K121594Device Name
COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
Manufacturer
Date Cleared
2012-10-25
(147 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free latex 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.
Device Description
Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm2
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K Number
K121591Device Name
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
Manufacturer
Date Cleared
2012-10-11
(133 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free latex examination glove with vanilla, grape and strawberry flavor 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
Flavoured, Powder Free And Polymer Coated Latex Examination Glove (Vanilla, Grape and Strawberry) With A Protein Claim Of Less Than 50ug/dm2
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K Number
K121192Device Name
NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
Manufacturer
Date Cleared
2012-08-03
(106 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder free nitrile 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.
Device Description
Colored Powder Free And Polymer Coated Nitrile Examination Glove (White, Blue and Black)
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K Number
K100694Device Name
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
Manufacturer
Date Cleared
2010-06-25
(106 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.
Device Description
A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.
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K Number
K013317Device Name
TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2001-12-17
(74 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Tekmedic Powder-Free Latex Patient Examination Gloves with Aloe Vera Coating and Protein Content Labeling Claim of 50 Micrograms or Less of Total Water Extractable Protein Per Gram
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K Number
K000555Device Name
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O
Manufacturer
Date Cleared
2000-04-12
(54 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K994250Device Name
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Manufacturer
Date Cleared
2000-02-07
(53 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Tekmedic Powder-Free Latex Examination Gloves, with Protein Labeling Claim (50 Micrograms or Less)
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K Number
K971949Device Name
POWDER-FREE PATIENT EXAMINATION GLOVES
Manufacturer
Date Cleared
1997-07-28
(61 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TEKMEDIC (M) SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A medical glove is worn on the hand. of health care and similar personnel to prevent contamination between healthcare personnel and the patient.
Device Description
Tekmedic Powder-Free LATEX Examination Gloves
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