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510(k) Data Aggregation
K Number
K213739Device Name
Nitrile Examination Gloves
Manufacturer
Date Cleared
2022-06-22
(205 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Runheng Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The device is powder free nitrile examination gloves. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.
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K Number
K213736Device Name
Medical Face Mask
Manufacturer
Date Cleared
2022-03-31
(122 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Runheng Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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