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510(k) Data Aggregation
K Number
K223281Device Name
Disposable Nitrile Examination Glove
Date Cleared
2022-12-07
(43 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui Kindguard Medical Supplies Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Nitrile 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 subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.
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