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510(k) Data Aggregation
K Number
K210898Device Name
Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
Manufacturer
Date Cleared
2021-08-26
(153 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Tangshan Lanhai Medical Supplies Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Nitrile Examination Gloves (Powder free, Purple-Blue, 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, Purple-Blue, 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 and color. The color of the proposed device is Blue and Purple-Blue. The proposed device is not provided as sterilized. The proposed device is made of Nitrile.
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