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510(k) Data Aggregation
K Number
K211904Device Name
Vinyl Glove
Manufacturer
Date Cleared
2021-09-17
(88 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Dihong Industry and Trade Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vinyl Glove is 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 vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
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K Number
K211252Device Name
Nitrile Glove
Manufacturer
Date Cleared
2021-06-25
(60 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Dihong Industry and Trade Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nitrile 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 powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
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