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510(k) Data Aggregation
K Number
K163553Device Name
Powder Free Nitrile Patient Examination Gloves, Blue
Date Cleared
2017-05-22
(154 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powder free nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The proposed device, Powder Free Nitrile Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Patient Examination Gloves, and includes variations of different size and color. The colors of proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
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