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510(k) Data Aggregation
K Number
K200093Device Name
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug
Manufacturer
Date Cleared
2020-08-20
(217 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui lntco Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The synthetic nitrile patient examination gloves, powder free, blue color and tested for use with chemotherapy drugs are disposable devices intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The glove was tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
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