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510(k) Data Aggregation
K Number
K213187Device Name
Disposable Nitrile Medical Powder-free Glove
Manufacturer
Date Cleared
2022-01-03
(96 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Fujian Chunhui Medical Supply Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Nitrile Medical Powder-free Glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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