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510(k) Data Aggregation
K Number
K240021Device Name
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Manufacturer
Date Cleared
2024-04-08
(96 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Yue Kang Anhui Medical Products Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Powder Free Nitrile Examination Gloves 3.5, Blue Color, Non-Sterile, and 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, Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTMD6978- 05(2019). The gloves are single use, disposable, and provided non-sterile.
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