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510(k) Data Aggregation
K Number
K242533Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Manufacturer
Better Care Plastic Technology Co., Ltd.
Date Cleared
2025-03-18
(204 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Better Care Plastic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
Device Description
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL.
Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05. The gloves are single use, disposable, and provided non-sterile.
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K Number
K232266Device Name
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Manufacturer
Better Care Plastic Technology Co., Ltd.
Date Cleared
2023-11-03
(95 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Better Care Plastic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Device Description
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
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K Number
K232070Device Name
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
Manufacturer
Better Care Plastic Technology Co., Ltd.
Date Cleared
2023-10-11
(91 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Better Care Plastic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019).
Device Description
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.
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K Number
K231567Device Name
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
Manufacturer
Better Care Plastic Technology Co., Ltd.
Date Cleared
2023-10-04
(126 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Better Care Plastic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.
Device Description
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small. Medium. Large. Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.
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K Number
K222449Device Name
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
Manufacturer
Better Care Plastic Technology Co., Ltd.
Date Cleared
2022-08-27
(12 days)
Product Code
LZC, LZA, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Better Care Plastic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Device Description
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
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K Number
K221269Device Name
Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Manufacturer
Better Care Plastic Technology Co., Ltd.
Date Cleared
2022-07-27
(86 days)
Product Code
LZA, LZC, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Better Care Plastic Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)
Device Description
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes = Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
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K Number
K140816Device Name
POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
Manufacturer
BETTER CARE PLASTIC TECHNOLOGY CO., LTD.
Date Cleared
2014-07-08
(98 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BETTER CARE PLASTIC TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is disposable non-sterile device intended for medical purpose 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 times are as follows:
| Test Chemotherapy Drug and Concentration | Average BDT |
|-------------------------------------------------|-------------|
| Fluorouracil, 50.0mg/ml (50,000ppm) | >240 min. |
| Etoposide (Toposar), 20.0mg/ml (20,000ppm) | >240 min. |
| Cyclophosphamide (Cytoxan), 20mg/ml (20,000ppm) | >240 min. |
| Carmustine (BCNU), 3.3mg/ml (3,300ppm) | 2.3 min. |
| Thiotepa, 10.0mg/ml (10,000ppm) | 30.9 min. |
| Paclitaxel (Taxol), 6.0mg/ml (6,000ppm) | >240 min. |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 min. |
| Dacarbazine (DTIC), 10.0mg/ml (10,000ppm) | >240 min. |
| Cisplatin, 1.0mg/ml (1,000ppm) | >240 min. |
Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.
Device Description
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.
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