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510(k) Data Aggregation
K Number
K211581Device Name
Disposable Nitrile Examination Gloves (Powder free, Blue)
Date Cleared
2021-10-28
(160 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Leping Shengde Medical Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) 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, DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
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