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Found 5 results
510(k) Data Aggregation
K Number
K231029Device Name
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
Manufacturer
Zhonghong Pulin Medical Products Co.,Ltd.
Date Cleared
2023-10-30
(202 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Zhonghong Pulin Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K230662Device Name
Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Manufacturer
Zhonghong Pulin Medical Products Co.,Ltd.
Date Cleared
2023-10-26
(230 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Zhonghong Pulin Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers 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 D6978-05 Standard Practice for Assessment of Medical gloves to Permention by Chemotherapy Drugs.
Device Description
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, blue colored, nitrile, and tested for use with chemotherapy drugs And Fentanyl Citrate. The design of the subject device is addressing the standards as ASTM D6124, ASTM D5151, ASTM D6319, ASTM D6978-05. The gloves have a minimum length of 270mm. The Subject device is nonsterile.
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K Number
K222534Device Name
Nitrile Patient Examination Glove
Manufacturer
Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.
Date Cleared
2022-11-23
(93 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
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K Number
K210723Device Name
Nitrile Patient Examination Glove
Manufacturer
Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.
Date Cleared
2021-07-12
(124 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
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K Number
K210460Device Name
NitriTec Vinyl Glove Powder Free Blue
Manufacturer
Zhonghong Pulin Medical Products Co.,Ltd.
Date Cleared
2021-05-17
(90 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Zhonghong Pulin Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
Device Description
NitriTec Vinyl Glove Powder Free Blue
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