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510(k) Data Aggregation
K Number
K202003Device Name
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Manufacturer
Date Cleared
2021-02-24
(219 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GMP Medicare SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
This glove was tested for use with chemotherapy drugs and Fentanyl Citrate as pet ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
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K Number
K182382Device Name
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
Manufacturer
Date Cleared
2019-08-29
(363 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GMP Medicare SDN BHD (F25)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
Device Description
Not Found
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K Number
K172867Device Name
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
Manufacturer
Date Cleared
2018-05-10
(232 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GMP MEDICARE SDN BHD (F25)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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.
Device Description
Nitrile Examination Powder Free Glove, Black; Nitrile Powder Free Glove, Orange
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K Number
K163017Device Name
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Manufacturer
Date Cleared
2017-03-22
(145 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GMP MEDICARE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
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K Number
K152222Device Name
NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
Manufacturer
Date Cleared
2016-04-21
(258 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
GMP MEDICARE SDN BHD (F25)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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:
Chemotherapy Drug Permeation
- The following chemicals have been tested with these gloves
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|----------------------------|---------------|----------------------------------------|
| Carmustine (BCNU) | 3.3mg/ml | *10.1 |
| Cisplatin | 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | >240 |
| 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 | *20.2 |
| Amethopterin Hydrate | 25.0mg/ml | >240 |
| Methotrexate | 25.0mg/ml | >240 |
| Mitomycin C | 0.5mg/ml | >240 |
| Vincristine Sulfate | 1.0mg/ml | >240 |
* Please note that the following drugs have extremely low permeation times:
Carmustine (BCNU): 10.1 minutes and Thiotepa: 20.2 minutes
Device Description
Nitrile Blue Powder Free 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.
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