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510(k) Data Aggregation
K Number
K213848Device Name
Medical nitrile examination gloves (Model: JL001)
Manufacturer
Date Cleared
2022-03-25
(105 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Guangdong Jiali Pharmaceutical Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medical nitrile examination gloves 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 a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, including small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface and has a rolled rim at the cuff edge.
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