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Found 12 results
510(k) Data Aggregation
K Number
K172923Device Name
Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
Manufacturer
Top Glove Sdn. Bhd.
Date Cleared
2018-04-26
(213 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Top Glove Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 standard practice for assessment of medical gloves to permeation by chemotherapy drugs.
Device Description
Nitrile Examination Powder Free Glove, White, Black, Orange Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
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K Number
K122999Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
2012-11-30
(64 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs glove is a disposable device intended for medical purpose 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 ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time in<br>Minutes, 0.01 ug/cm2/minute |
|---|--------------------------------------------------|-----------------------------------------------------------------------|
| 1 | Cisplatin, 1.0 mg/ml (1,000ppm) | >240 |
| 2 | Cyclophosphamide (Cytoxan),20.0mg/ml (20,000ppm) | >240 |
| 3 | Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 |
| 4 | Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| 5 | Etoposide (Toposar), 20.0 mg/ml (20,000)ppm | >240 |
| 6 | Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 |
| 7 | Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 |
| 8 | Carmustine (BCNU)3.3mg/ml(3,300ppm) | 0.9 |
| 9 | Thiotepa, 10.0mg/ml (10,000ppm) | 0.05 |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes
> Carmustine (BCNU)3.3mg/ml(3,300ppm) Thiotepa, 10.0mg/ml ( 10,000ppm)
Device Description
Not Found
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K Number
K023974Device Name
ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
2003-02-13
(73 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
Device Description
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND - PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
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K Number
K021855Device Name
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
2002-08-05
(60 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Latex examination powderfree gloves are worn on the hands 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
K993664Device Name
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
2000-01-11
(74 days)
Product Code
LYZ, DAT
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthetic Vinyl Medical Examination Powdered Gloves are worn on the hands of Health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
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K Number
K993452Device Name
GREEN POWDERED LATEX EXAMINATION GLOVES
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
1999-12-20
(68 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Powdered Green Latex Examination Gloves (vith minimum length of 280mm) are worn on the hands of Health care and similar personnel to give an additional protection until the arm to prevent contamination between health care personnel and the patient especially for the Emergency Medical Service.
Device Description
Powdered Green Latex Examination Glove
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K Number
K993605Device Name
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
1999-12-20
(56 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Pepper Green Mint Powdered Latex Examination Gloves are worn on the hands 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
K993680Device Name
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
1999-12-13
(42 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
Device Description
SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
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K Number
K990690Device Name
POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
1999-05-20
(78 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
Device Description
Polymer Coated Powder-Free Latex Examination Gloves
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K Number
K990468Device Name
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
Manufacturer
TOP GLOVE SDN. BHD.
Date Cleared
1999-04-27
(70 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TOP GLOVE SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALITE CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
Device Description
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELLING (100 MICROGRAM OR LESS)
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