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510(k) Data Aggregation
K Number
K213843Device Name
Nitrile Examination Gloves
Manufacturer
Date Cleared
2022-03-31
(112 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Dong Tai City Huayi Gloves Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The subject device is a single use, powder free nitrile examination glove. The subject device is black. It can be available in four specifications: S,M,L,XL. The subject device is non-sterile, ambidextrous.
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