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510(k) Data Aggregation
K Number
K212036Device Name
Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs
Manufacturer
Date Cleared
2021-10-05
(97 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Yanfang Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation 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 or fingers to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
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K Number
K203805Device Name
Disposable Nitrile Examination Gloves
Manufacturer
Date Cleared
2021-04-20
(113 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Yanfang Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Nitrile Examination Gloves is intended for medical purposes that is worn on the examiner's hands 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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