Search Results
Found 2 results
510(k) Data Aggregation
K Number
K240072Device Name
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
Date Cleared
2024-02-09
(30 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Luliang Hongruida Health Protection Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, gloves were tested for use with Chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978.
Device Description
Powder Free Nitrile Examination Gloves (Blue, Purple-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, 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).
Ask a Question
Ask a specific question about this device
K Number
K213440Device Name
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
Date Cleared
2022-02-18
(116 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Luliang Hongruida Health Protection Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs 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 using ASTM D6978 and will be labeled with a statement of compliance and a summary of the testing results.
Device Description
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs 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 as per ASTM D6978-05(2019).
Ask a Question
Ask a specific question about this device
Page 1 of 1