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510(k) Data Aggregation
K Number
K222815Device Name
Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl
Manufacturer
Date Cleared
2022-12-04
(76 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Zibo Lanhua Medical Packaging Material Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free Nitrile Examination Gloves, Blue, Test For Use With Chemotherapy Drugs and Fentary) 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 in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes.
The Powder Free Nitrile Examination Gloves, White, Test For Use With Chemotherapy Drugs and Fentanyl 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 in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
The Powder Free Nittile Examination Gloves, Black,Test For Use With Chemotherapy Drugs and Fentary 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 in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.
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